LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

NCT04175197 | Unknown

• 1 other identifier: LEGDEB2 v.3.1
• Study Type: observational
• Target: 512
• Locations: 2 countries
• Sites: 7

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

Conditions

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

Keywords

Stenosis; Drug Coated Balloon; Paclitaxel; Artery Disease

Outcome Measures

Primary Outcomes (2)

• Efficacy: Freedom from Clinically driven TLR

  Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: * Any re-intervention within the target lesion(s) due to symptoms

  12 Months

• Safety: Freedom from MAE

  A composite of freedom from device- and procedure-related mortality through 30 days, freedom from device or procedure related mortality, freedom from any cardiac or cardiovascular death, freedom from major target limb amputation

  30 days

Secondary Outcomes (9)

• Freedom from MALE and MACCE

  30 days, 6 Months, 12 Months, 24 Months, 36 Months

• Freedom from all cause mortality

  30 days, 6 Months, 12 Months, 24 Months, 36 Months

• Freedom from CD-TLR

  24 Months, 36 Months

• Freedom from CD-TVR

  6 Months, 12 Months, 24 Months, 36 Months

• Freedom from Major target limb amputation

  30 days, 6 Months, 12 Months, 24 Months, 36 Months

Study Arms (1)

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

Device: Drug Coated Balloon

Interventions

Drug Coated Balloon DEVICE

Legflow Drug Coated Balloon

Study Cohort

Eligibility Criteria

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

Study Population

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 iliac arterial occlusion or stenosis will be consecutively screened and enrolled based on the study inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (7)

Policlinico di Monza

Monza, Italy

Location

Università Federico II - Dipartimento Scienze Biomediche Avanzate

Napoli, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Angeles del Carmen

Guadalajara, Mexico

Location

Consulta Privada Cardiovascular Research Institute

Guadalajara, Mexico

Location

Hospital Angeles Mocel

Mexico City, Mexico

Location

Hospital Lopez Mateos

Mexico City, Mexico

Location

Related Publications (1)

• 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.

  PMID: 30760132 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases; Chronic Limb-Threatening Ischemia; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Pathological Conditions, Anatomical

Central Study Contacts

Eugenio Stabile, Prof.

CONTACT

+39 081 7462239; eugenio.stabile@unina.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiovascular Medicine

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 22, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

ME (4); IT (3)