Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.

iVascular

Status: Completed

Conditions: Peripheral Vascular Disease

Treatments: Device: Paclitaxel-eluting balloon

Study type: Observational

Funder types: Industry

Identifiers

NCT02458911

Luminor

Details and patient eligibility

About

The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 & luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and restenosis from prior endovascular procedures in this sector.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes aged at least 18

• Primary injuries and restenosis of the infrainguinal sector of AFS, AP and ATs, and intrastent restenosis or post-ATP prior in that sector.

  • Stenosis >50% and occlusions. (image test)
  • Length: 20 to 200 mm
  • Artery diameter: 2-7 mm.

• Symptomatic patients (grades 2-5 Rutherford-Baker both included; Fontaine II-IV), affected in their quality of life and that accept treatment (moderate / severe claudication patients, critical ischemia without gangrene or injuries severe enough to foresee limb amputation).

Exclusion criteria

• Patients with acute or subacute ischemia will be excluded.
• Existence of flow-limiting lesions in arteries of the "in flow" or the "out flow" of the sector or artery under treatment (> 50 % of the arterial diameter).
• Aneurysmal dilatation in the ipsilateral arterial axis.
• Intolerance / allergy to heparin, thienopyridine derivatives (clopidogrel , ticlopidine) and aspirin.
• Hemorrhagic diathesis during the 3 months prior to inclusion.
• Patients with a life expectancy of less than 12 months.
• Serious allergy to contrasts or PTX.
• Inability to cross the lesion with the guide (these cases will be recorded for the analysis as "intention to treat).
• Those participating simultaneously in another clinical trial.
• Pregnancy or lactation (pregnancy tests on fertiles).