Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

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

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

Study Overview

• Status: Completed
• Conditions: In-stent Arterial Restenosis
• Intervention / Treatment: Device: uncoated AngioSculpt(R); Combination product: Drug coated AngioSculpt(R)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Danta Pazzanese Heart Institute
• Germany
  • Homburg Saar, Germany, 66421
    • Internal Medicine III, UKS
  • Leipzig, Germany
    • Herzzentrum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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)
Active Comparator: uncoated AngioSculpt(R); Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)	Device: uncoated AngioSculpt(R); Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late lumen loss in-segment	angiographic late lumen loss in-segment assessed by quantitative coronary angiography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Saarland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 20, 2011

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FIM-DCA-01