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.

NCT02458911 | Completed DMC

• 1 other identifier: Luminor
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (2)

• Primary patency

  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.

  1 year

• Freedom of adverse events

  Freedom of adverse effects (AE). EA are considered in combination: death, amputation and the need for revascularization of the target lesion (safety objective).

  1 year

Interventions

Paclitaxel-eluting balloon DEVICE

Also known as: Luminor 14 & Luminor 35

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral artery disease due to occlusive lesions, stenosis of ingraguinal arteries and restenosis after previous angioplasty with/without stent in that sector

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (1)

Hospital Universitario Getafe

Getafe, Madrid, 28907, Spain

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: May 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

ES (1)