Clinical trial NCT01495533: Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter
Official title: Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: In-stent Arterial Restenosis
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.

Detailed description: Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* clinical evidence of stable or unstable angina or a positive functional study
* patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)

Exclusion Criteria:

* acute myocardial infarction within the past 72 hours
* chronic renal insufficiency with serum creatinine levels \>2.0 mg per deciliter%
* known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
* concomitant medical illness associated with a life-expectancy of less than two years
* stented segment length ≥30 mm, vessel diameter \<2.5 mm, diameter stenosis \<70%

Primary outcomes:
measure: late lumen loss in-segment
timeFrame: 6 months
Secondary outcomes:
measure: Procedural Success
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: Major adverse cardiovascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Danta Pazzanese Heart Institute
city: Homburg Saar
country: Germany
facility: Internal Medicine III, UKS
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
Study officials:
References:
citation: Scheller B, Fontaine T, Mangner N, Hoffmann S, Bonaventura K, Clever YP, Chamie D, Costa R, Gershony G, Kelsch B, Kutschera M, Genereux P, Cremers B, Bohm M, Speck U, Abizaid A. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv. 2016 Jul;88(1):51-9. doi: 10.1002/ccd.26216. Epub 2015 Sep 2.