NCT02905214

Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

Coroflex ISAR 2000 Extended Postmarket Surveillance Non-Interventional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,369 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries.

Detailed description

The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DEVICE	stenting with the Coroflex ISAR sirolimus-eluting stent	coronary stenting

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-01
• Completion: 2021-12-01
• First posted: 2016-09-19
• Last updated: 2022-02-08

Locations

3 sites across 3 countries: Germany, Malaysia, Spain