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Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter

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ClinicalTrials.gov Identifier: NCT01495533
Recruitment Status : Unknown
Verified May 2014 by University Hospital, Saarland.
Recruitment status was:  Active, not recruiting
First Posted : December 20, 2011
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study
Study Start Date : December 2011
Primary Completion Date : December 2013
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. late lumen loss in-segment [ Time Frame: 6 months ]
    angiographic late lumen loss in-segment assessed by quantitative coronary angiography


Secondary Outcome Measures :
  1. Procedural Success [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 days ]
    <50% final DS and the absence of in-hospital MACE

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01495533     History of Changes
Other Study ID Numbers: FIM-DCA-01
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action