LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

NCT ID: NCT04175197

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 512 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Cohort

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

Drug Coated Balloon

Intervention Type: DEVICE

Legflow Drug Coated Balloon

Interventions

Drug Coated Balloon

Legflow Drug Coated Balloon

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Eugenio Stabile

Associate Professor of Cardiovascular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico di Monza

Monza, , Italy

Università Federico II - Dipartimento Scienze Biomediche Avanzate

Napoli, , Italy

Policlinico Umberto I

Roma, , Italy

Angeles del Carmen

Guadalajara, , Mexico

Consulta Privada Cardiovascular Research Institute

Guadalajara, , Mexico

Hospital Angeles Mocel

Mexico City, , Mexico

Hospital Lopez Mateos

Mexico City, , Mexico

Countries

Italy; Mexico

Central Contacts

Eugenio Stabile, Prof.

Role: CONTACT

eugenio.stabile@unina.it

+39 081 7462239

Facility Contacts

Giovanni Sorropago, MD

Role: primary

Eugenio Stabile, Prof.

Role: primary

eugenio.stabile@unina.it

Francesco Speziale, Prof.

Role: primary

Gustavo Rubio, MD

Role: primary

Luis Virgen, MD

Role: primary

Alfonso Espinosa, MD

Role: primary

Jorge Torres, MD

Role: primary

References

Stabile E, Gerardi D, Magliulo F, Zhelev D, Chervenkoff V, Taeymans K, Kotasov D, Goverde P, Giugliano G, Trimarco B, Esposito G. One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry. J Endovasc Ther. 2019 Feb;26(1):26-30. doi: 10.1177/1526602818823557.

Reference Type: RESULT

PMID: 30760132 (View on PubMed)

Other Identifiers

LEGDEB2 v.3.1

Identifier Type: -

Identifier Source: org_study_id