Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)

Active, not recruiting

• Conditions: Peripheral Arterial Occlusive Disease

• Registration Number: NCT02460042
• Lead Sponsor: B. Braun Melsungen AG

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)

Study Timeline

• Study First Submitted: 2015-02-26
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Primary Completion: 2018-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Revascularization Rate	12 months	rate of target lesion revascularization (interventional, surgical)

Secondary Outcome Measures

Name	Time	Method
Maximum Walking Distance (MWD)	5 years	maximum walking distance under standardized conditions
Amputation rate	12/24 months and 3/5 years	Amputation rate at 12/24 months and 3/5 years and 'freedom from amputation' Kaplan-Meier curve
Patency rate	5 years	Patency rates as observed using non-invasive Duplex ultrasound
Procedural success	1 day	Procedural success to pass and treat the lesions (remaining stenosis is 30 %)
Rutherford classification distribution change at all follow-up intervals	12/24 months and 3/5 years	Rutherford classification distribution change at all follow-up intervals
Target Lesion Revascularization Rate (TLR)	24 months	Target Lesion Revascularization Rate at 24 months\* to establish a 'freedom from TLR' Kaplan-Meier curve
Ankle Brachial Index (ABI)	5 years	ankle brachial index
Rutherford classifications per group at all follow-up intervals	12/24 months and 3/5 years	Rutherford classifications per group at all follow-up intervals

Trial Locations

Locations (1)

St. Gertrauden Krankenhaus; 🇩🇪 Berlin, Germany