LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

Peripheral Arterial Disease Clinical Trial

— LEGDEB2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04175197
• Other study ID #: LEGDEB2 v.3.1
• Status: Not yet recruiting
• Start date: November 2019
• Est. completion date: December 2024

Study information

• Verified date: November 2019
• Source: Federico II University
• Contact: Eugenio Stabile, Prof.
• Phone: +39 081 7462239
• Email: eugenio.stabile[@]unina.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 512
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Constriction, Pathologic
• Critical Limb Ischemia
• Iliac Artery Stenosis
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Popliteal Artery Stenosis
• Superficial Femoral Artery Stenosis

Intervention

Device:
• Drug Coated Balloon
Legflow Drug Coated Balloon

Locations

Country	Name	City	State
Italy	Policlinico di Monza	Monza
Italy	Università Federico II - Dipartimento Scienze Biomediche Avanzate	Napoli
Italy	Policlinico Umberto I	Roma
Mexico	Hospital Angeles Mocel	Ciudad de Mexico
Mexico	Hospital Lopez Mateos	Ciudad de Mexico
Mexico	Angeles del Carmen	Guadalajara
Mexico	Consulta Privada Cardiovascular Research Institute	Guadalajara

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Countries where clinical trial is conducted

Italy,  Mexico, 

References & 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 End — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Freedom from all cause mortality	all cause mortaliy	30 days, 6 Months, 12 Months, 24 Months, 36 Months
Secondary	Freedom from CD-TLR	Clinically driven Target Lesion Revascularization	24 Months, 36 Months
Secondary	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
Secondary	Freedom from Major target limb amputation	Major target limb amputation	30 days, 6 Months, 12 Months, 24 Months, 36 Months
Secondary	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
Secondary	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
Secondary	Procedural Success	Procedural success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate	Day 1
Secondary	Clinical Success	Clinical success is defined as procedural success without in hospital MALE and/or MACCE	Day 1