Clinical trial NCT04175197: LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
Official title: The LegDeb2 Global Registry for the Treatment of Superficial Femoral, Popliteal or Below-The-Knee Artery Lesions Using the Legflow DrugEluting Balloon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Efficacy: Freedom from Clinically driven TLR
timeFrame: 12 Months
measure: Safety: Freedom from MAE
timeFrame: 30 days
Secondary outcomes:
measure: Freedom from MALE and MACCE
timeFrame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
measure: Freedom from all cause mortality
timeFrame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
measure: Freedom from CD-TLR
timeFrame: 24 Months, 36 Months
measure: Freedom from CD-TVR
timeFrame: 6 Months, 12 Months, 24 Months, 36 Months
measure: Freedom from Major target limb amputation
timeFrame: 30 days, 6 Months, 12 Months, 24 Months, 36 Months
measure: Primary sustained clinical improvement
timeFrame: 6 Months, 12 Months, 24 Months, 36 Months
measure: Device Success
timeFrame: Day 1
measure: Procedural Success
timeFrame: Day 1
measure: Clinical Success
timeFrame: Day 1
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Policlinico di Monza
city: Napoli
country: Italy
facility: Università Federico II - Dipartimento Scienze Biomediche Avanzate
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Ciudad de Mexico
country: Mexico
facility: Hospital Angeles Mocel
city: Ciudad de Mexico
country: Mexico
facility: Hospital Lopez Mateos
city: Guadalajara
country: Mexico
facility: Angeles del Carmen
city: Guadalajara
country: Mexico
facility: Consulta Privada Cardiovascular Research Institute
Study officials:
References:
citation: 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.