Treatment of iliac atherosclerotic lesions using the balloon-expandable dynamic bare metal stent: One-year outcomes of the BIODYNAMIC single-center retrospective analysis

Vascular ◽  
2020 ◽  
pp. 170853812094542
Author(s):  
Giovanni F Torsello ◽  
Beatrix Doerr ◽  
Konstantinos Donas ◽  
Bärbel Berekoven ◽  
Giovanni B Torsello ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Iliac Artery ◽  
Common Iliac Artery ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Limb Amputation ◽  
Single Center ◽  
Atherosclerotic Lesions ◽  
Treatment Standard ◽  
Stent System

Objectives Endovascular therapy using balloon expandable stents has become the treatment standard for most iliac atherosclerotic lesions. We aimed to assess the safety and performance of the Dynamic stainless-steel balloon-expanding stent system in this location. Methods BIODYNAMIC is a retrospective single center study including consecutive patients with iliac lesions treated with the Dynamic stent system. Not included were implantations inside an endograft. The primary endpoint was freedom from major adverse limb events (MALE) at 12 months, defined as index limb amputation or target lesion revascularization (TLR). Secondary endpoints were procedure success, ankle brachial index (ABI) and Rutherford class change, mortality and freedom from TLR after 12 months. Results Within two years, 182 patients with 234 lesions in the common iliac artery were enrolled. Rutherford class 5 and 6 were present in 11.5% of patients, average stent diameter was 8.0 ± 0.5 mm and stented length 40.0 ± 15.3 mm. The primary endpoint was reached in 96.2% (225/234) of the cases, with six TLR (2.6%) and three target limb amputations (1.3%). Procedure success was obtained in all but three patients (98.4%). In paired analysis, ABI improved by 0.25 ± 0.21 from baseline to 0.90 ± 0.16 post-procedure and Rutherford class improved by −1.75 ± 1.53. There were four non-device–related deaths (2.2%). Freedom from TLR was 97%, 95.3%, 94% and 92.7% at 24, 36, 48 and 60 months, respectively. Conclusion The Dynamic balloon-expandable stent system proved to be safe and effective in a population with common iliac artery lesions.

Photoablative atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis in instent femoro-popliteal obstructions (PHOTOPAC)

VASA ◽  
2021 ◽  
pp. 1-7
Author(s):  
Tanja Böhme ◽  
Elias Noory ◽  
Ulrich Beschorner ◽  
Frederik Lerke ◽  
Andrej Schmidt ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Small Sample ◽  
Adverse Event Rate ◽  
Control Cohort ◽  
Procedural Success ◽  
Laser Atherectomy

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

Single-Center Experience and 1-Year Follow-up Results of “Sandwich Technique” in the Management of Common Iliac Artery Aneurysms During EVAR

2012 ◽  
Vol 35 (5) ◽  
pp. 1195-1200 ◽  
Author(s):  
Carmelo Ricci ◽  
Claudio Ceccherini ◽  
Marco Cini ◽  
Francesco Vigni ◽  
Sara Leonini ◽  
...  
Keyword(s):  
Iliac Artery ◽  
Common Iliac Artery ◽  
Single Center ◽  
Sandwich Technique ◽  
Single Center Experience

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.

scholarly journals Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months

2017 ◽  
Vol 24 (3) ◽  
pp. 342-348 ◽  
Author(s):  
John H. Rundback ◽  
Patrick Peeters ◽  
Jon C. George ◽  
Michael R. Jaff ◽  
Peter L. Faries
Keyword(s):  
Iliac Artery ◽  
Ankle Brachial Index ◽  
External Iliac Artery ◽  
Patient Characteristics ◽  
The United States ◽  
Target Lesion ◽  
Primary Patency ◽  
Specific Patient ◽  
Target Vessel Revascularization ◽  
Primary Stenting

Purpose: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Methods: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2–4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Results: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Conclusion: Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

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.

Spontaneous Common Iliac Artery Dissection After Exercise

2003 ◽  
Vol 10 (1) ◽  
pp. 163-166 ◽  
Author(s):  
Lip Gen Teh ◽  
Kishore Sieunarine ◽  
Greg van Schie ◽  
Thodur Vasudevan
Keyword(s):  
Iliac Artery ◽  
Common Iliac Artery ◽  
Artery Dissection

Common Iliac Artery Access During Endovascular Thoracic Aortic Repair Facilitated by a Transabdominal Wall Tunnel

2001 ◽  
Vol 8 (2) ◽  
pp. 135-138 ◽  
Author(s):  
Sumaira Macdonald ◽  
Dominique Byrne ◽  
Paul Rogers ◽  
Jonathan G. Moss ◽  
Richard D. Edwards
Keyword(s):  
Iliac Artery ◽  
Common Iliac Artery ◽  
Aortic Repair

scholarly journals The feasibility of the flower stenting technique for ostial lesions of the common iliac artery

2021 ◽  
Vol 4 (3) ◽  
Author(s):  
Toshihiko Kishida ◽  
Keisuke Hirano ◽  
Shinsuke Mori ◽  
Masahiro Yamawaki ◽  
Norihiro Kobayashi ◽  
...  
Keyword(s):  
Iliac Artery ◽  
Common Iliac Artery ◽  
The Common
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