Results of a European multicentre iliac stent trial with a flexible balloon expandable stent

Reekers, Jim A.; Vorwerk, Dierk; Rousseau, Hervé; Sapoval, Marc; Gaines, P. A.; Stockx, L; Delcour, Christian; Raat, H; Voshage, Götz; Biamino, Giancarlo; Hoogeveen, Yvonne L.

doi:10.1053/ejvs.2002.1775

Cited by 34 publications

(27 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The primary 9-month patency of 95.8% and the 95.8% 9-month freedom from CD-TVR are consistent with prior nonrandomized reports for both balloon-expandable and self-expanding stents. 1,2,4,6–9 In addition, there was a high rate of both initial and sustained patient-reported benefit, consistent with the findings of the iliac stent cohort treated in the Endovascular Revascularization And Supervised Exercise for claudication (ERASE) study. 18 …”

Section: Discussionsupporting

confidence: 63%

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

et al. 2017

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 63%

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

et al. 2017

View full text Add to dashboard Cite

show abstract

“…One of the possible pitfalls of community-based SET is the use of numerous physiotherapeutic practices (30) and physiotherapists (41), which results in a lower patient volume for each physiotherapist than occurs in a clinic-based setting. For this reason, we decided to implement a NETP and refer patients only to physiotherapists who participate in this network, instead of to any physiotherapist.…”

Section: Resultsmentioning

confidence: 99%

“…Many patients keep or regain symptoms of intermittent claudication after a vascular intervention, despite the fact that the treated segment is patent (28)(29)(30)(31). At this point the possible value of SET should be explored.…”

Section: Future Perspectivesmentioning

confidence: 99%

Supervised Exercise Therapy for Intermittent Claudication

Bendermacher

Kruidenier²,

Nicolaï³

et al. 2007

Acta Chirurgica Belgica

View full text Add to dashboard Cite

show abstract

“…Literature-reported mean ABI improvements at 6 or 12 months ranging from 0.19 to 0.37 were similar to what was observed in patients treated with the EPIC stent, where ABI showed sustained improvement through 12 months. 10,15,24,25,33 Limitations of the ORION trial are unlikely to have impacted the overall outcomes of thê^T trial, as results are consistent, if not better, than data from contemporary trials. However, the non-randomized trial did not include a direct head-to-head comparator and relied on published literature at the time of protocol conception.…”

Section: Discussionmentioning

confidence: 99%

The EPIC Nitinol Stent System in the Treatment of Iliac Artery Lesions: One-Year Results From the ORION Clinical Trial

Clair¹,

Adams²,

Reen³

et al. 2014

Journal of Endovascular Therapy

View full text Add to dashboard Cite

show abstract

Results of a European multicentre iliac stent trial with a flexible balloon expandable stent

Cited by 34 publications

References 8 publications

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

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

Supervised Exercise Therapy for Intermittent Claudication

The EPIC Nitinol Stent System in the Treatment of Iliac Artery Lesions: One-Year Results From the ORION Clinical Trial

Contact Info

Product

Resources

About