PTA and Stenting of Femoropopliteal Trunk With Cordis Smartflex Stent System: A Single-Center Experience

Introduction: The aim of this study is to describe our experience in the treatment of femoropopliteal occlusive disease with percutaneous transluminal angioplasty (PTA) followed by stenting with S.M.A.R.T. Flex vascular stent system. Materials and Methods: From June 2014 to October 2018, 80 patients were treated at our Institution for intermittent claudication, critical, or acute limb ischemia due to total occlusion or long diffused lesions of the femoropopliteal segment. Main study end points are primary patency, target lesion revascularization, and stent fractures; secondary end points are major amputation rate, procedure-related bleeding, incidence of intrastent restenosis, and primary assisted patency after reintervention. Results: Mean follow-up time was 21 months (range 2-48 months). Primary patency rate was 80% (64 patients of 80), with mean covered lesion length of 8.2 cm. The deployment of a single stent was obtained for 57 (89%) patients, with a mean stent length of 9.86 cm. Of 80 patients, 2 (2.5%) had early stent occlusion within first 48 hours after the procedure, while 4 (5%) of 80 patients experienced stent occlusion within first 6 months. Of 80 patients, 6 (7.5%) had an intrastent restenosis detected at duplex ultrasound with a primary-assisted patency after simple re-PTA procedures of 83.3% at 12 months. Discussion: In the literature, primary patency after PTA and stenting of the femoropopliteal trunk seems to be related to several variables, such as number of stents used, specific stent length, diameters, type and length of lesions, type of pathology (if acute or chronic), and number of preoperatory patent below-the-knee vessels. In this study, we try to analyze each single factor in order to understand their role in predisposing specific stent restenosis. Conclusions: S.M.A.R.T. Flex vascular stent system has shown good results in terms of primary patency in the treatment of calcified lesions both at SFA and at popliteal level. However, in our experience, stent patency seems to be significantly poorer in patients presenting with acute limb ischemia associated with chronic atherosclerotic disease as well as for lesions located in the mid-distal part of the popliteal artery and both when number of stents increases or number of runoff vessel decreases.

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Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial

Journal of Endovascular Therapy ◽

10.1177/1526602820980419 ◽

2020 ◽

pp. 152660282098041

Author(s):

Timothy M. Sullivan ◽

Thomas Zeller ◽

Masato Nakamura ◽

Peter A. Gaines ◽

Keyword(s):

De Novo ◽

Ankle Brachial Index ◽

Target Lesion ◽

Primary Patency ◽

Lesion Length ◽

Stent Fracture ◽

Vascular Stent ◽

Stent Patency ◽

Kaplan Meier ◽

Stent System

Purpose To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. Materials and Methods The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial ( ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. Results The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. Conclusion Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

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BioMimics 3D vascular stent system for femoropopliteal interventions

VASA ◽

10.1024/0301-1526/a000980 ◽

2021 ◽

Author(s):

Michael Lichtenberg ◽

Thomas Zeller ◽

Peter Gaines ◽

Michael Piorkowski

Keyword(s):

Real World ◽

Target Lesion ◽

Primary Patency ◽

Distribution Functions ◽

Target Lesion Revascularization ◽

Limb Amputation ◽

Lesion Length ◽

Vascular Stent ◽

Safety Outcome ◽

Stent System

Summary: Background: The MIMICS-3D study aimed to assess the safety and effectiveness of the BioMimics 3D Vascular Stent System for the treatment of symptomatic femoropopliteal artery disease in a real-world patient population. Patients and methods: Consecutive participants who were scheduled for implantation of the BioMimics 3D stent were enrolled in the prospective, observational, multicenter study. The primary effectiveness outcome was freedom from clinically driven target lesion revascularization at 12 months and the primary safety outcome was a composite of major adverse events comprising death, major target limb amputation, or clinically driven target lesion revascularization at 30 days. Outcomes through 24 months are reported. Results: A total of 507 patients (70±10 years, 65.5% male sex) were enrolled and treated with the study stent. 24.0% had critical limb-threatening ischemia, lesion length was 127±92 mm, and 56.8% of lesions were totally occluded. The Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization at twelve-months was 90.6% (95% CI: 87.9%–93.3%) and the 30-day primary safety outcome occurred in 1.2% (95% CI: 0.5%–2.7%) of participants. At 24 months, clinical improvement was achieved in 86.6% and the KM estimate of freedom from clinically driven target lesion revascularization was 82.8% (95% CI: 79.4%–86.4%). The KM estimate of freedom from loss of primary patency according to PSVR >2.4 was 78.6% (95% CI: 74.7%–82.4%). Survival distribution functions regarding primary patency were lower with long lesions (>150 mm; log-rank p<0.001) but did not differ significantly between participants with or without critical limb-threatening ischemia (log-rank p=0.07). Conclusions: Endovascular treatment of atherosclerotic femoropopliteal lesions with the BioMimics 3D Vascular Stent System is efficacious and safe in a real-world setting.

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One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia

Journal of Endovascular Therapy ◽

10.1177/1526602817697319 ◽

2017 ◽

Vol 24 (3) ◽

pp. 311-316 ◽

Cited By ~ 6

Author(s):

Marc Bosiers ◽

Joren Callaert ◽

Koen Keirse ◽

Jeroen M. H. Hendriks ◽

Patrick Peeters ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Duplex Ultrasound ◽

Limb Ischemia ◽

Target Lesion ◽

Primary Patency ◽

Drug Eluting Stent ◽

Lesion Length ◽

Imaging Data ◽

Stent System

Purpose: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. Methods: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0–58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). Results: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. Conclusion: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

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Atrial Fibrillation is Associated with Femoropopliteal Totally Occlusive In-Stent Restenosis: A Single-Center, Retrospective, Observational Study

Journal of Interventional Cardiology ◽

10.1155/2021/8852466 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

Yohsuke Honda ◽

Keisuke Hirano ◽

Masahiro Yamawaki ◽

Motoharu Araki ◽

Norihiro Kobayashi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cox Regression ◽

De Novo ◽

Limb Ischemia ◽

Hazard Ratio ◽

Acute Limb Ischemia ◽

Stent Occlusion ◽

Stent Restenosis ◽

Artery Disease ◽

In Stent Restenosis

Introduction. The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions. Methods. In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion. Results. Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p = 0.004 ). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p = 0.0001 ). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR ( p = 0.71 ) for ALI ( p = 0.79 ). Conclusions. AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion.

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Stenting in the Carotid Artery: Initial Experience in 110 Patients

Journal of Endovascular Therapy ◽

10.1177/152660289600300112 ◽

1996 ◽

Vol 3 (1) ◽

pp. 42-62 ◽

Cited By ~ 74

Author(s):

Edward B. Diethrich ◽

Mouhamadou Ndiaye ◽

Donald B. Reid

Keyword(s):

Carotid Artery ◽

Positive Impact ◽

Clinical Success ◽

Balloon Dilation ◽

Carotid Stenting ◽

Primary Patency ◽

Lesion Length ◽

Technical Failure ◽

Stent Occlusion ◽

Asymptomatic Patients

Purpose: To evaluate the feasibility, safety, and efficacy of intravascular stents in the treatment of extracranial carotid artery occlusive disease. Methods: According to protocol, stent therapy was offered to symptomatic patients with ≥ 70% arteriographically defined carotid stenoses or ulcerative lesions and, after September 1994, to asymptomatic patients with ≥ 75% stenoses. From April 1993 to September 1995, 110 nonconsecutive patients (79 males; mean age 72 years, range 45 to 85) consented to participate in the study. The majority (79 [72%]) were asymptomatic. Lesions meeting the treatment criteria were in the proximal common (n = 3); mid common (n = 12); distal common (n = 8); internal (ICA) (n = 92); and external (n = 2) carotid arteries. Seven patients had bilateral ICA stenoses, and 17 patients were treated for postsurgical recurrent disease. The mean lesion length and diameter stenosis for all lesions were 12.4 ± 9.2 mm and 86.5% ± 10.6%, respectively. The procedures were performed either via direct percutaneous access to the cervical common carotid artery or through a retrograde femoral artery approach. Standard balloon dilation preceded deployment of balloon-expandable stents in most cases. No postprocedural anticoagulation was used (aspirin only). Results: In 110 patients (117 arteries) intended for treatment, 109 (99.0%) (116 arteries [99.1%]) were successfully treated with 129 stents (128 Palmaz, 1 Wallstent). One percutaneous procedure failed (0.9%) for technical reasons (stent could not be deployed) and was converted to carotid endarterectomy. Minor complications included 4 cases of spasm (successfully treated with papaverine); 1 flow-limiting dissection (stented); and 6 access-site problems. There were 7 strokes (2 major, 5 reversible) (6.4%) and 5 minor transient events (4.5%) that resolved within 24 hours. Three patients were converted to endarterectomy (2.7%) prior to discharge; 1 stroke patient expired (0.9%), and another patient died of an unrelated cardiac event in hospital. In the 30-day postprocedural period, 2 ICA stents occluded (patients asymptomatic). Clinical success at 30 days (no technical failure, death, endarterectomy, stroke, or occlusion) was 89.1% (98/110). Over a mean 7.6-month follow-up (range 2 to 31), no new neurological symptoms developed. Another stent occlusion at 2 months and one case of flow-limiting intimal hyperplasia at 7 months were detected on routine duplex scanning in asymptomatic patients. Life-table analysis shows an 89% cumulative primary patency rate. Conclusions: Based on this early experience, carotid stenting appears feasible from a technical standpoint, with good midterm patency. However, the incidence of neurological sequelae is a serious problem. Technical enhancements and a more aggressive antiplatelet regimen may have a positive impact on these events.

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Single Tertiary Care Center Outcomes After Lower Extremity Cadaveric Vein Bypass for Limb Salvage

Vascular and Endovascular Surgery ◽

10.1177/1538574420925586 ◽

2020 ◽

Vol 54 (5) ◽

pp. 430-435

Author(s):

Kuldeep Singh ◽

Amandeep Juneja ◽

Tushar Bajaj ◽

Christian Voto ◽

Jonathan Schor ◽

...

Keyword(s):

Lower Extremity ◽

Limb Salvage ◽

Saphenous Vein ◽

Tertiary Care ◽

Limb Ischemia ◽

Primary Patency ◽

Limb Amputation ◽

Secondary Patency ◽

Acute Limb Ischemia ◽

Long Term Outcome

Objective: Cadaveric saphenous vein (CV) conduits are used in rare instances for limb salvage in patients without autogenous veins although long-term outcome data are scarce. This study was designed to evaluate the outcomes of CV bypass in patients with threatened limbs. Methods: We retrospectively reviewed the charts from 2010 to 2017 of 25 patients who underwent 30 CV allografts for critical limb ischemia and acute limb ischemia. Patient charts were reviewed for demographics, comorbidities, smoking status, indications for bypass, and outcomes. Primary outcomes included graft patency, major amputation rates, and mortality. Secondary outcomes measured included infection rates, 30-day major adverse cardiac events (MACE) and major adverse limb events (MALE). Statistical analysis was performed using time series and Kaplan-Meier survival curves. Results: A total of 30 limbs received CV lower extremity bypasses (20 males, 10 female), and the average age was 68 ± 4 years. Primary patency rates were 71%, 42%, and 28% at 3, 6, and 12 months, respectively. Assisted primary patency rates were 78%, 56%, and 37% at 3, 6, and 12 months, respectively. Secondary patency rates were 77%, 59%, and 28% at 3, 6, and 12 months, respectively. Minor amputations, defined as amputations below the transmetatarsal level occurred in 5 (20%) patients. Wound infection occurred in 8 (32%) patients which was managed with local wound care and no patients required an extraanatomic bypass for limb salvage. Thirty-day MALE occurred in 7 (23.3%) patients. We had no 30-day mortality or MACE. The average graft length was 64.2 ± 8 cm with an average graft diameter of 3.9 ± 2 mm. Amputation-free survival and overall survival at 12 months were 20 (68%) and 21 (84%), respectively. Conclusions: Cadaveric saphenous vein allograft may be used as a bypass conduit as a viable surgical option before limb amputation. Despite the poor patency rates, the limb salvage rates of cadaveric vein grafts demonstrate that this alternate conduit may be considered when no autogenous vein is available.

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The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population

Angiology ◽

10.1177/0003319721997314 ◽

2021 ◽

pp. 000331972199731

Author(s):

Ralf Langhoff ◽

Jawed Arjumand ◽

Matthias Waliszewski ◽

Peter Reimer ◽

Dirk Härtel ◽

...

Keyword(s):

Balloon Catheter ◽

Limb Ischemia ◽

Target Lesion ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Lesion Length ◽

Multicenter Observational Study ◽

Technical Success Rate ◽

All Cause Mortality ◽

Artery Disease

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)’s used was 99.6% (1.60 ± 0.79 DCB’s/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). Predictors for TLR were in-stent restenosis at baseline, vessel diameters ≤ 4.5 mm, lesion length, and post-DCB bailout stenting.

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The role of directional atherectomy in critical-limb ischemia

Therapeutic Advances in Cardiovascular Disease ◽

10.1177/17539447211046953 ◽

2021 ◽

Vol 135 ◽

pp. 175394472110469

Author(s):

Prakash Krishnan ◽

Arthur Tarricone ◽

Simon Chen ◽

Samin Sharma

Keyword(s):

Lower Extremity ◽

Limb Salvage ◽

Critical Limb Ischemia ◽

Relevant Literature ◽

Limb Ischemia ◽

Primary Patency ◽

Lesion Length ◽

Secondary Patency ◽

Directional Atherectomy ◽

Procedural Success

Background: Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia. Methods: A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded. Results: Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm. Conclusions: DA may be a useful tool in the treatment of lower extremity critical-limb ischemia.

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One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial

Journal of Endovascular Therapy ◽

10.1177/1526602817740133 ◽

2017 ◽

Vol 25 (1) ◽

pp. 100-108 ◽

Cited By ~ 8

Author(s):

Aljoscha Rastan ◽

James F. McKinsey ◽

Lawrence A. Garcia ◽

Krishna J. Rocha-Singh ◽

Michael R. Jaff ◽

...

Keyword(s):

Popliteal Artery ◽

Duplex Ultrasound ◽

Limb Ischemia ◽

Clinical Results ◽

Major Amputation ◽

Primary Outcome Measure ◽

Primary Patency ◽

Walking Distance ◽

Lesion Length ◽

Directional Atherectomy

Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound–defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients.

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Endovascular Treatment of Severely Calcified Femoropopliteal Lesions Using the “Pave-and-Crack” Technique: Technical Description and 12-Month Results

Journal of Endovascular Therapy ◽

10.1177/1526602818763352 ◽

2018 ◽

Vol 25 (3) ◽

pp. 334-342 ◽

Cited By ~ 11

Author(s):

Marina Dias-Neto ◽

Manuela Matschuck ◽

Yvonne Bausback ◽

Ursula Banning-Eichenseher ◽

Sabine Steiner ◽

...

Keyword(s):

Limb Ischemia ◽

Target Lesion ◽

Major Amputation ◽

Lesion Length ◽

Secondary Patency ◽

Technical Success ◽

Stent Patency ◽

Kaplan Meier ◽

The Mean ◽

Peripheral Arterial

Purpose: To report midterm results of the “pave-and-crack” technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. Methods: Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to “pave” the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was “cracked” before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method. Results: Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%. Conclusion: Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal “pave-and-crack” technique.

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