Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm

2019 ◽  
Vol 26 (5) ◽  
pp. 637-642 ◽  
Author(s):  
Martin Werner ◽  
Fatemeh Gomari-Grisar ◽  
Silvia Belalcazar ◽  
Mirko Hirschl ◽  
Georg Kalchhauser ◽  
...  
Keyword(s):  
Velocity Ratio ◽  
Treatment Algorithm ◽  
Peak Systolic Velocity ◽  
Target Lesion ◽  
Primary Patency ◽  
Lesion Length ◽  
Secondary Patency ◽  
Vascular Stent ◽  
Modern Treatment

Purpose: To prospectively evaluate the safety and efficacy of the TIGRIS Vascular Stent in the superficial femoral artery (SFA) and proximal popliteal artery within a treatment algorithm that reserved stent usage for more challenging patients. Materials and Methods: This prospective, single-center study enrolled 97 patients (mean age 68.7 years; 66 men) who were treated for 100 de novo or nonstented restenotic femoropopliteal lesions (≥70% stenosis) and had recoil or dissection after plain balloon predilation. The average lesion length was 5.6±2.3 cm (maximum 8 cm per protocol). The composite primary efficacy outcome was 12-month primary patency, defined as a peak systolic velocity ratio ≤2.5 at the stented target lesion on duplex ultrasound, and no clinically-driven reintervention within the stented segment. The primary safety outcome was freedom from device- and procedure-related target vessel revascularization, target limb major amputation (above the metatarsals), or death through 30 days. Secondary outcomes included secondary patency, clinically-driven target lesion revascularization (TLR), Rutherford category change relative to baseline, and binary restenosis of the target lesion. Results: All devices were successfully implanted with no device-related complications at the time of implant or within the 30-day postimplant window. The average stented length was 7.0±2.5 cm; no stent elongation was observed during deployment. One patient was lost to follow-up before 12 months and another died of an unrelated cause, leaving 95 patients (98 lesions) available for 12-month follow-up and 77 patients/lesions for the 24-month preliminary analysis. The binary primary and secondary patency rates at 12 months were 92.9% and 100%. The binary freedom from TLR was 94.9%. At 24 months, the Kaplan-Meier estimate of primary patency was 90.0%. Conclusion: This prospective study demonstrated that the TIGRIS Vascular Stent is a safe and effective device in a modern treatment algorithm that reserved bare stent use for postangioplasty dissection or recoil in distal femoropopliteal arteries.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions

2020 ◽  
Vol 27 (2) ◽  
pp. 287-295 ◽  
Author(s):  
Marc Bosiers ◽  
Carlo Setacci ◽  
Gianmarco De Donato ◽  
Giovanni Torsello ◽  
Pierre Galvagni Silveira ◽  
...  
Keyword(s):  
Treatment Group ◽  
Complication Rate ◽  
Bypass Surgery ◽  
Velocity Ratio ◽  
Bypass Graft ◽  
Peak Systolic Velocity ◽  
Target Lesion ◽  
Primary Patency ◽  
Surgical Bypass ◽  
Zilver Ptx

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft ( ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

Rotational and aspiration atherectomy for infrainguinal in-stent restenosis

VASA ◽  
2013 ◽  
Vol 42 (2) ◽  
pp. 127-133 ◽  
Author(s):  
Ulrich Beschorner ◽  
Hans Krankenberg ◽  
Dierk Scheinert ◽  
Horst Sievert ◽  
Thilo Tübler ◽  
...  
Keyword(s):  
Ankle Brachial Index ◽  
Primary Patency ◽  
Study Endpoint ◽  
Primary Study ◽  
Lesion Length ◽  
Secondary Patency ◽  
Peripheral Vascular ◽  
Stent Restenosis ◽  
In Stent Restenosis

Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. Patients and methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

Abstract 6189: Stent Fracture does not Affect Long Term Patency in the Femoro-popliteal Artery: Four Years Experience

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Osamu Iida ◽  
Shinsuke Nanto ◽  
Masaaki Uematsu ◽  
Takakazu Morozumi ◽  
Tetsuya Watanabe ◽  
...  
Keyword(s):  
Time Course ◽  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Primary Patency ◽  
Stent Fracture ◽  
X Ray ◽  
Nitinol Stents ◽  
Provisional Stenting

[Background] Stent fracture in the femoro-popiteal (FP) artery has been related to poor long term patency. However, time course of patency with and without stent fracture beyond 2 years has not been explored. [Methods] We studied consecutive 334 FP lesions that received provisional stenting with metallic or nitinol stents (Luminexx, Bard: 90 lesions and Smart, Cordis: 243 lesions). Stent fracture was determined by X-ray with multiple projections. Patency was either assessed by Duplex ultrasonography as peak systolic velocity ratio > 2.5 or by angiography (% diameter stenosis > 50%). [Results] Stent fracture occurred in 19% (55/334) lesions and restenosis rate at mean follow up (16+/−12 months) was 20% (67/334). Primary patency with or without stent fracture was 83% with fracture versus 68% without fracture at 1 year, p=0.03; 75% versus 60% at 2 years, p=0.04; 68% versus. 60% at 3 years, p=0.05; 63% versus 60% at 4 years, p=0.06. [Conclusion] Stent fracture affected the patency during the first 2 years, but unlikely affected the patency beyond 4 years.

scholarly journals BioMimics 3D vascular stent system for femoropopliteal interventions

VASA ◽  
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.

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months

2021 ◽  
pp. 152660282110648
Author(s):  
Edward Choke ◽  
Tjun Yip Tang ◽  
Eilane Peh ◽  
Karthikeyan Damodharan ◽  
Shin Chuen Cheng ◽  
...  
Keyword(s):  
Pilot Study ◽  
Limb Salvage ◽  
Velocity Ratio ◽  
Human Study ◽  
Peak Systolic Velocity ◽  
Primary Patency ◽  
Limb Amputation ◽  
Lesion Length ◽  
Below The Knee ◽  
All Cause Mortality

Introduction: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). Material and Methods: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. Results: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001) and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%). Conclusions: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.

Impact of Cilostazol Administration on Femoropopliteal In-Stent Restenosis

2017 ◽  
Vol 24 (5) ◽  
pp. 640-646 ◽  
Author(s):  
Yusuke Tomoi ◽  
Yoshimitsu Soga ◽  
Osamu Iida ◽  
Masahiko Fujihara ◽  
Kenji Ando
Keyword(s):  
Positive Impact ◽  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Target Lesion ◽  
Stent Restenosis ◽  
Secondary Endpoints ◽  
The Mean ◽  
Negative Predictor ◽  
In Stent Restenosis

Purpose: To investigate whether administering cilostazol after treatment for femoropopliteal in-stent restenosis (ISR) can have a positive impact on recurrent ISR (Re-ISR). Methods: The database of a multicenter, retrospective, observational registry was interrogated to identify 338 consecutive patients (mean age 72.3±8.8 years; 148 men) who underwent endovascular therapy for femoropopliteal ISR in 379 limbs from January 2010 to December 2014. Ninety-seven patients (103 limbs) who received cilostazol after the initial stent implantation procedure were excluded. This left 24 ISR patients (30 limbs) who received cilostazol initially after ISR treatment for comparison with 217 ISR patients (246 limbs) who did not receive the drug. The primary endpoint was 2-year Re-ISR after treatment. The secondary endpoints were recurrent target lesion revascularization (Re-TLR) and reocclusion at 2 years. Restenosis was determined by a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography. Results: The mean follow-up was 23.3±15.5 months. At 2 years, freedom from Re-ISR was significantly higher in the cilostazol group than in the no cilostazol group (48.6% vs 32.4%, p=0.047). However, freedom from Re-TLR and reocclusion between the 2 groups did not differ significantly [64.7% vs 53.8% (p=0.15) and 88.3% vs 73.9% (p=0.11), respectively]. After adjusting for prespecified risk factors, cilostazol administration was a negative predictor of Re-ISR. Conclusion: This small comparative study suggests that administering cilostazol for ISR lesions after femoropopliteal stenting reduces recurrent ISR.

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

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.

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial

2020 ◽  
pp. 152660282096596
Author(s):  
Tanja Böhme ◽  
Elias Noory ◽  
Klaus Brechtel ◽  
Dierk Scheinert ◽  
Marc Bosiers ◽  
...  
Keyword(s):  
Clinical Success ◽  
Target Lesion ◽  
Primary Patency ◽  
Stent Fracture ◽  
Secondary Patency ◽  
Primary Patency Rate ◽  
Target Vessel Revascularization ◽  
Kaplan Meier ◽  
Secondary Endpoints

Purpose: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries. Materials and Methods: This prospective, multicenter, single-arm trial ( ClinicalTrials.gov; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2–4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture. Results: Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up. Conclusion: The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.

scholarly journals Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

2020 ◽  
Vol 27 (2) ◽  
pp. 296-303 ◽  
Author(s):  
Jaafer Golzar ◽  
Yoshimitsu Soga ◽  
Anvar Babaev ◽  
Osamu Iida ◽  
Daizo Kawasaki ◽  
...  
Keyword(s):  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Target Lesion Revascularization ◽  
Drug Eluting Stent ◽  
Kaplan Meier ◽  
Drug Eluting

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

2017 ◽  
Vol 51 (2) ◽  
pp. 60-66 ◽  
Author(s):  
Alessia Giaquinta ◽  
Ardita Vincenzo ◽  
Ester De Marco ◽  
Massimiliano Veroux ◽  
Pierfrancesco Veroux
Keyword(s):  
Wound Healing ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Lesion Length ◽  
Free Survival ◽  
Tibial Arteries

Background: Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions. Objectives: This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm. Methods: All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis >70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1- and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates. Results: Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1- and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency ( P = .022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing. Conclusions: The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.

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