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

The LegDeb2 Global Registry for the Treatment of Superficial Femoral, Popliteal or Below-The-Knee Artery Lesions Using the Legflow DrugEluting Balloon

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

Study Overview

• Status: Not yet recruiting
• Conditions: Arterial Occlusive Diseases; Peripheral Arterial Disease; Popliteal Artery Stenosis; Critical Limb Ischemia; Superficial Femoral Artery Stenosis; Iliac Artery Stenosis
• Intervention / Treatment: Device: Drug Coated 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.

• Study Type: Observational
• Enrollment (Anticipated): 512

Contacts and Locations

• Study Contact: Name: Eugenio Stabile, Prof.; Phone Number: +39 081 7462239; Email: eugenio.stabile@unina.it

Study Locations

• Italy
  • Monza, Italy
    • Policlinico di Monza
    • Contact: Giovanni Sorropago, MD
  • Napoli, Italy
    • Università Federico II - Dipartimento Scienze Biomediche Avanzate
    • Contact: Eugenio Stabile, Prof.; Email: eugenio.stabile@unina.it
  • Roma, Italy
    • Policlinico Umberto I
    • Contact: Francesco Speziale, Prof.
    • Principal Investigator: Francesco Speziale, Prof
    • Sub-Investigator: Pasqualino Sirignano, MD
• Mexico
  • Ciudad de Mexico, Mexico
    • Hospital Angeles Mocel
    • Contact: Alfonso Espinosa, MD
  • Ciudad de Mexico, Mexico
    • Hospital Lopez Mateos
    • Contact: Jorge Torres, MD
  • Guadalajara, Mexico
    • Angeles del Carmen
    • Contact: Gustavo Rubio, MD
  • Guadalajara, Mexico
    • Consulta Privada Cardiovascular Research Institute
    • Contact: Luis Virgen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Legflow Drug Coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from MALE and MACCE	MALE is defined as acute limb ischemia, urgent revascularization or mayor amputation of the treated limb MACCE is defined as Death, Acute myocardial infarction or stroke	30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from all cause mortality	all cause mortaliy	30 days, 6 Months, 12 Months, 24 Months, 36 Months
Freedom from CD-TLR	Clinically driven Target Lesion Revascularization	24 Months, 36 Months
Freedom from CD-TVR	Clinically driven Target Vessel Revascularization Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms	6 Months, 12 Months, 24 Months, 36 Months
Freedom from Major target limb amputation	Major target limb amputation	30 days, 6 Months, 12 Months, 24 Months, 36 Months
Primary sustained clinical improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	6 Months, 12 Months, 24 Months, 36 Months
Device Success	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).	Day 1
Procedural Success	Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate	Day 1
Clinical Success	Clinical success is defined as procedural success without in hospital MALE and/or MACCE	Day 1

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Stenosis; Paclitaxel; Drug Coated Balloon; Artery Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Pathological Conditions, Anatomical; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases; Constriction, Pathologic
• Other Study ID Numbers: LEGDEB2 v.3.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No