Peripheral Arterial Disease Clinical Trial
— LEGDEB2Official title:
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy, Mexico,
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
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 |
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