SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries

Recruiting

• Conditions: Peripheral Arterial Disease; Superficial Femoral Artery Stenosis; Angiopathy, Peripheral

• Registration Number: NCT04971772
• Lead Sponsor: Cardionovum GmbH

Brief Summary

The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Study Start: 2022-06-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-10
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint:	12 months post-procedure	The primary efficacy endpoint is time to clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms OR drop of ankle brachial index (ABI) \> 20 % OR ABI \> 0.15 compared to the post-procedural ABI.
Device- and procedure-related death	30 days post-procedure	Primary Safety Endpoint: Freedom from device- and procedure-related death through 30 days post-index procedure;
Major target limb amputation and clinically-driven target vessel revascularization	12 months post-procedure	Primary Safety Endpoint: A composite of (2.1) time to major target limb amputation (above-the-ankle (ATA)) through 12 months post-procedure and (2.2) time to clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure

Secondary Outcome Measures

Name	Time	Method
Acute device success	during index procedure	defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure
Secondary safety endpoint at discharge up to 30 days post-index procedure	30 days post-operative	Secondary safety endpoint is a composite of (3.1) freedom from all cause death (3.2) freedom from major target limb amputation (3.3) freedom from CD-TVR
Sustained clinical improvement at 6-, 12- and 24- months post-index procedure	6, 12, 24-months post-procedure	Clinical improvement is defined as a composite of (4.1) freedom from major target limb amputation, (4.2) freedom from TVR, (4.3) freedom from worsening target limb Rutherford class (compared to baseline) (4.4) freedom from decrease in target limb ankle brachial index (ABI) ≥0.15 (compared to baseline)
Target Vessel Revascularization at 6-, 12- and 24-months post-index procedure	6, 12, 24-months post-procedure	defined as a reintervention to maintain or restore the patency in the target vessel. TVR is clinically-driven (CD) when the TVR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure
Acute procedural success	during index procedure	Acute procedural success is defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram.
Binary restenosis at 6-, 12- and 24-months	6, 12, 24-months post-procedure	defined as a restenosis confirmed by DUS PSVR ≥2.4 or ≥50% stenosis (For 12-month: assessed by Independent Core-Lab)
Change in target limb Rutherford Classification from baseline to 6-, 12- and 24-months	6, 12, 24-months post-procedure	Change in Target Limb Rutherford Classification from baseline to 6-, 12- and 24-months
device- and procedure-related death	30- days, 6, 12, 24-months post-procedure	Freedom from device- and procedure-related death at discharge, 30 days, 6-, 12- and 24-months
Primary Patency at 6-, 12- and 24-months	6, 12, 24-months post-procedure	The primary patency is defined as a composite of (6.1) freedom from clinically-driven target lesion revascularization (CD-TLR); (6.2) freedom from binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis); • For discharge and 12-months: assessed by independent Core Lab
Target Lesion Revascularization at 6-, 12- and 24-months post-index procedure	6, 12, 24-months post-procedure	defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure.
Thrombosis at the target lesion at 6-, 12- and 24-months	6, 12, 24-months post-procedure	Thrombosis at the target lesion at 6-, 12- and 24-months
Major Adverse Events (MAEs) at 6-, 12- and 24-months post-index procedure	6, 12, 24-months post-procedure	MAEs are defined as composite of (5.1) all-cause death, (5.2) CD-TVR (5.3) major target limb amputation (5.4) thrombosis at the target lesion
Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months	6, 12, 24-months post-procedure	Change in Target Limb Resting ABI or TBI from baseline to 6-, 12- and 24-months
Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ-5D Questionnaire to baseline at follow-up at 6-, 12- and 24-month.	6, 12, 24-months post-procedure	Improvement of life quality according to the Walking Impairment Questionnaire (WIQ) and the EQ-5D Questionnaire to baseline at follow-up at 6-, 12- and 24-month.
Major Target Limb Amputation at 6-, 12- and 24-months	30- days, 6, 12, 24-months post-procedure	defined as an amputation above the ankle (ATA) in the target limb
All-cause death at 6-, 12- and 24-months	30- days, 6, 12, 24-months post-procedure	All-cause death at 6-, 12- and 24-months

Trial Locations

Locations (6)

Sankt Gertrauden-Krankenhaus Berlin; 🇩🇪 Berlin, Germany

Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH; 🇩🇪 Hamburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

SRH Klinikum Karlsbad-Langenseinbach GmbH; 🇩🇪 Karlsbad, Germany

St. Franziskus-Hospital GmbH; 🇩🇪 Münster, Germany

GRN-Klinik Weinheim; 🇩🇪 Weinheim, Germany