Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01495533
First received: December 13, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
In-stent Arterial Restenosis
Device: uncoated AngioSculpt(R)
Device: Drug coated AngioSculpt(R)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • late lumen loss in-segment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    angiographic late lumen loss in-segment assessed by quantitative coronary angiography


Secondary Outcome Measures:
  • Procedural Success [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 days ] [ Designated as safety issue: No ]
    <50% final DS and the absence of in-hospital MACE

  • Major adverse cardiovascular events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    the occurence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months (before planned control angiography)


Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo 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)
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)
Device: 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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495533

Locations
Brazil
Danta Pazzanese Heart Institute
Sao Paolo, Brazil
Germany
Internal Medicine III, UKS
Homburg Saar, Germany, 66421
Herzzentrum Leipzig
Leipzig, Germany
Sponsors and Collaborators
University Hospital, Saarland
  More Information

No publications provided

Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01495533     History of Changes
Other Study ID Numbers: FIM-DCA-01
Study First Received: December 13, 2011
Last Updated: May 5, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection

Additional relevant MeSH terms:
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014