LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries (LEGDEB2)

Federico II University

Status: Not yet enrolling

Conditions: Superficial Femoral Artery Stenosis; Popliteal Artery Stenosis; Critical Limb Ischemia; Arterial Occlusive Diseases; Peripheral Arterial Disease; Iliac Artery Stenosis

Treatments: Device: Drug Coated Balloon

Study type: Observational

Funder types: Other

Identifiers

NCT04175197

LEGDEB2 v.3.1

Details and patient eligibility

About

LEGDEB2 is a Global Registry for the Treatment of Superficial Femoral and/or Popliteal or Below-The-Knee or Iliac Artery Lesions Using the Legflow Drug-Eluting Balloon

Full description

LEGDEB2 is a Global Registry aimed to prospectively collect and assess global safety and efficacy data on the Legflow Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal and/or below-the-knee and/or iliac arteries in "real world" patient population.

Enrollment: 512 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years or minimum age as required by local regulations.

• Subject with documented diagnosis of lower extremities arterial disease (LEAD).
• Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
• Positive diagnostic indication for PTA with a DEB in accordance with the Instructions For Use (IFU) of the Legflow DEB.
• Adequate distal run-off to the ankle (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment.
• Adequate inflow (≤ 50% diameter stenosis) either pre-existing or successfully re-established prior to target lesion treatment.
• Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before enrollment.
• Signed and dated Patient Informed Consent (PIC) form.
• Ability and willingness to comply with the clinical investigation plan (CIP).
• Life expectancy, in the Investigator's opinion, of at least 12 months

Exclusion criteria

• High probability of non-adherence to CIP follow-up requirements.
• Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
• Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
• Acute or sub-acute thrombus in the target vessel.
• Target lesion also requires treatment with alternative drug eluting technology-based therapy or other antiproliferative therapy (cryoplasty, brachytherapy).
• Plan for surgical or interventional procedure within 30 days after the study procedure (except for bilateral target limb treatment).
• Known allergies or sensitivities to heparin, aspirin, other anti- coagulant/anti-platelet therapies, and/or paclitaxel.

Trial design

512 participants in 1 patient group

Study Cohort

Description:

Subjects with symptoms of intermittent claudication and/or critical limb ischemia (Rutherford Class 2-3-4-5-6) with angiographic evidence of femoropopliteal-below-the-knee arterial occlusion or stenosis

Treatment:

Device: Drug Coated Balloon