Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

NCT01495533 | Completed Phase 3 DMC

• 1 other identifier: FIM-DCA-01
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

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.

Conditions

In-stent Arterial Restenosis

Outcome Measures

Primary Outcomes (1)

• late lumen loss in-segment

  angiographic late lumen loss in-segment assessed by quantitative coronary angiography

  6 months

Secondary Outcomes (2)

• Procedural Success

  participants will be followed for the duration of hospital stay, an expected average of 2 days

• Major adverse cardiovascular events

  6 months

Study Arms (2)

uncoated AngioSculpt(R)

ACTIVE COMPARATOR

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

Device: uncoated AngioSculpt(R)

drug coated AngioSculpt(R)

ACTIVE COMPARATOR

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)

Interventions

uncoated AngioSculpt(R) DEVICE

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

uncoated AngioSculpt(R)

Drug coated AngioSculpt(R) COMBINATION_PRODUCT

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

drug coated AngioSculpt(R)

Eligibility Criteria

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

You may qualify if:

• \>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)

You may not qualify if:

• 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%

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (3)

Danta Pazzanese Heart Institute

São Paulo, Brazil

Location

Internal Medicine III, UKS

Homburg Saar, 66421, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Related Publications (1)

• 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.

  PMID: 26331782 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 20, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

DE (2); BR (1)