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.

Completed

• Conditions: Peripheral Vascular Disease

• Registration Number: NCT02458911
• Lead Sponsor: iVascular S.L.U.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-01
• Primary Completion: 2017-07
• Study Completion: 2017-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency	1 year	Primary patency (performance target) of the angioplasty (PTA) performed with drug eluting balloons (DEB) in stenotic/occlusive primary lesions, in restenosis of the AFS, AP and ATs, or in stents from previous procedures in these arteries, with follow-up of 12 months.
Freedom of adverse events	1 year	Freedom of adverse effects (AE). EA are considered in combination: death, amputation and the need for revascularization of the target lesion (safety objective).

Trial Locations

Locations (1)

Hospital Universitario Getafe; 🇪🇸 Getafe, Madrid, Spain