NCT00613418

Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery

Comparative Study of Safety and Efficacy of the SUPERA® Wire Interwoven Self-expanding Nitinol Stent and Currently Approved Stents for Patients With Iliac Lesions

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate derived from a meta-analysis of studies on iliac stents approved by FDA for treating subjects with de novo or restenotic lesions in the common and/or external iliac arteries.

Conditions

• With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries

Interventions

Type	Name	Description
DEVICE	IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System	Interwoven, self-expanding nitinol stent system, including delivery system and stent

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2008-02-13
• Last updated: 2019-05-09

Regulatory

• FDA-regulated device study