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

NCT04971772 | Active Not Recruiting DMC

• 1 other identifier: FCRE-210621
• Study Type: observational
• Target: 150
• Locations: 3 countries
• Sites: 11

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.

Conditions

Superficial Femoral Artery Stenosis; Angiopathy, Peripheral; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• Primary Efficacy Endpoint:

  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.

  12 months post-procedure

• Device- and procedure-related death

  Primary Safety Endpoint: Freedom from device- and procedure-related death through 30 days post-index procedure;

  30 days post-procedure

• Major target limb amputation and clinically-driven target vessel revascularization

  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

  12 months post-procedure

Secondary Outcomes (16)

• Acute device success

  during index procedure

• Acute procedural success

  during index procedure

• Secondary safety endpoint at discharge up to 30 days post-index procedure

  30 days post-operative

• Sustained clinical improvement at 6-, 12- and 24- months post-index procedure

  6, 12, 24-months post-procedure

• Major Adverse Events (MAEs) at 6-, 12- and 24-months post-index procedure

  6, 12, 24-months post-procedure

Study Arms (2)

DCB (Legflow .035") group

treatment with Drug Coated Balloon angioplasty with the Legflow .035" Paclitaxel Balloon Dilatation catheter.

POBA group

treatment with standard POBA (uncoated) angioplasty (type and brand at the physician's discretion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with peripheral arterial disease in the SFA, eligible for treatment with the paclitaxel coated Legflow dilatation balloon catheter

You may qualify if:

• Patient is ≥18 years
• Patient has Rutherford Classification 2,3 or4.
• Patient has provided written informed consent and is willing to comply with study follow-up requirements.
• De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusive lesion(s) occurring \>90 days after prior plain old balloon (POBA) angioplasty or \>180 days after prior DCB treatment.
• Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery
• Target vessel diameter ≥ 4 mm and ≤ 7 mm
• Target lesion must be stenotic or occlusive lesion ≤ 150mm in length (one long lesion or tandem lesions) by investigator's visual estimate. \[Note: tandem lesions must have a total length of ≤ 150 mm by visual estimate and be separated by ≤ 30 mm.\]
• Target lesion must have angiographic evidence of ≥ 70 % stenosis by investigator's visual estimation
• Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen. Subintimal dissection techniques may be used if re-entry occurs above-the-knee (ATK) and without the use of re-entry devices.
• Target lesion is located at least 30mm from any stent if target vessel was previously stented.
• A patent inflow artery free from significant stenosis ((≥50% stenosis) as confirmed by angiography.
• At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography.

You may not qualify if:

• Acute Limb Ischemia
• Patient underwent an intervention involving the target vessel within the previous 90 days.
• Patient underwent any lower extremity percutaneous treatment in the ipsilateral limb using plain old balloon (POBA) angioplasty within the previous 90 days.
• Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesion using a DCB within the previous 180 days.
• Pregnant women or women who are intending to become pregnant.
• Patient has a life expectancy of less than 1 year
• Patient has a known allergy to contrast medium that cannot be adequately pre-medicated.
• Patient is allergic to all anti-platelet treatments
• Patient is receiving immunosuppressant therapy
• Patient has platelet count \<100.000/mm3 or \>700.000/mm
• Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure
• Patient is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT)
• Patient has history of stroke within past 90 days
• Patient has history of myocardial infarction within the past 30 days.
• Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study.

Sponsors & Collaborators

• Cardionovum GmbH: lead
• FCRE (Foundation for Cardiovascular Research and Education): collaborator

Study Sites (11)

Coris Medicina Vascular

Florianópolis, 88020-210, Brazil

Location

Hospital Universitario da Universidade Federal de Santa Cataria

Florianópolis, 88040-900, Brazil

Location

Sankt Gertrauden-Krankenhaus Berlin

Berlin, State of Berlin, 10713, Germany

Location

Kreiskrankenhaus Alsfeld

Alsfeld, 36304, Germany

Location

Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Hamburg, 69469, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

SRH Klinikum Karlsbad-Langenseinbach GmbH

Karlsruhe, 76307, Germany

Location

St. Franziskus-Hospital GmbH

Münster, 48145, Germany

Location

GRN-Klinik Weinheim

Weinheim, 69120, Germany

Location

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

Location

Hôpital de la Providence

Neuchâtel, 2000, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 21, 2021
• Study Start: June 8, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); CH (2); BR (2)