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.

Peripheral Vascular Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458911
• Other study ID #: Luminor
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: November 21, 2017
• Start date: May 2014
• Est. completion date: September 2017

Study information

• Verified date: November 2017
• Source: iVascular S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Paclitaxel-eluting balloon

Locations

Country	Name	City	State
Spain	Hospital Universitario Getafe	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
iVascular S.L.U.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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