Overview

This trial is active, not recruiting.

Condition peripheral vascular disease
Treatment paclitaxel-eluting balloon
Sponsor iVascular S.L.U.
Start date May 2014
End date May 2017
Trial size 215 participants
Trial identifier NCT02458911, Luminor

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Primary patency
time frame: 1 year
Freedom of adverse events
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by iVascular S.L.U..