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Completed

NCT Number: NCT02458911

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Getafe

Getafe, Madrid, 28907, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Paclitaxel-eluting balloon

Device

Other names: Luminor 14 & Luminor 35

Primary outcomes

  1. Primary patency

    Time frame: 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.

  2. Freedom of adverse events

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

iVascular S.L.U.

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2015
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.