Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

In-stent Arterial Restenosis Clinical Trial

Official title:

Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495533
• Other study ID #: FIM-DCA-01
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: July 2014

Study information

• Verified date: April 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• In-stent Arterial Restenosis

Intervention

Device:
• uncoated AngioSculpt(R)
Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

Combination Product:
• Drug coated AngioSculpt(R)
Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)

Locations

Country	Name	City	State
Brazil	Danta Pazzanese Heart Institute	São Paulo
Germany	Internal Medicine III, UKS	Homburg Saar
Germany	Herzzentrum Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Countries where clinical trial is conducted

Brazil,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss in-segment	angiographic late lumen loss in-segment assessed by quantitative coronary angiography	6 months
Secondary	Procedural Success	<50% final DS and the absence of in-hospital MACE	participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary	Major adverse cardiovascular events	the occurence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months (before planned control angiography)	6 months