CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population

B. Braun Melsungen AG1 site in 1 country960 target enrollmentMay 2015

ConditionsPeripheral Arterial Occlusive Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Occlusive Disease
Sponsor: B. Braun Melsungen AG
Enrollment: 960
Locations: 1
Primary Endpoint: Target Lesion Revascularization Rate
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.

Detailed Description

This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

December 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

B. Braun Melsungen AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Target Lesion Revascularization Rate

Time Frame: 12 months

rate of target lesion revascularization (interventional, surgical)

Secondary Outcomes

Procedural success(1 day)
Rutherford classification distribution change at all follow-up intervals(12/24 months and 3/5 years)
Target Lesion Revascularization Rate (TLR)(24 months)
Ankle Brachial Index (ABI)(5 years)
Rutherford classifications per group at all follow-up intervals(12/24 months and 3/5 years)
Amputation rate(12/24 months and 3/5 years)
Patency rate(5 years)
Maximum Walking Distance (MWD)(5 years)