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Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH – ISR I)

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ClinicalTrials.gov Identifier: NCT00106587
Recruitment Status : Completed
First Posted : March 28, 2005
Last Update Posted : November 11, 2005
Sponsor:
Information provided by:
University Hospital, Saarland

Brief Summary:
The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.

Condition or disease Intervention/treatment Phase
Coronary Restenosis Device: paclitaxel coated balloon catheter (device with drug) Phase 1 Phase 2

Detailed Description:

Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR.

Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=52 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 25 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons
Study Start Date : December 2003
Estimated Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. angiographic late lumen loss

Secondary Outcome Measures :
  1. binary restenosis rate
  2. major adverse cardiac events


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:

  • Age > 18 years
  • Clinical evidence of stable or unstable angina or a positive functional study
  • Single, restenotic lesion in a stented coronary artery (allowed are multiple lesions but only the target lesion is amenable for percutaneous intervention, i.e. no ‘staged’ procedures involving non-target lesions)
  • Diameter stenosis > 70% (visual estimate)
  • Stented segment length < 25 mm
  • Vessel diameter => 2.5 mm
  • Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
  • Signed patient informed consent form
  • Patients and treating physicians agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

Exclusion Criteria:

  • Left ventricular ejection fraction of < 30%
  • Target lesion/vessel with any of the following characteristics: Clear angiographic calcification in the target lesion or greater than mild calcification in the proximal vessel (minimally radiopaque densities that are discrete and non-linear). Visible thrombus proximal to the lesion.
  • Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated.
  • Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy causing the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
  • Severe chronic renal insufficiency.
  • Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and/or requires additional anti-platelet and/or anti-coagulation treatment.
  • Participating in another device or drug study within the last 6 months

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): NCT00106587


Locations
Germany
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany, 66421
Kardiologie, Campus Mitte, Charite
Berlin, Germany, 10117
Kardiologie, Campus Virchow-Klinikum, Charite
Berlin, Germany, 13353
Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie
Freiburg, Germany, 79106
I. Medizinische Klinik, Universitaetsklinikum
Mannheim, Germany, 68167
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Bruno Scheller, MD Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes, 66421 Homburg/Saar, Germany
Study Director: Ulrich Speck, PhD Radiologie, Campus Mitte, Charite, Berlin, Germany

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00106587     History of Changes
Other Study ID Numbers: BMT – Pac 1
First Posted: March 28, 2005    Key Record Dates
Last Update Posted: November 11, 2005
Last Verified: March 2005

Keywords provided by University Hospital, Saarland:
in stent restenosis
paclitaxel coated balloon catheter
paccocath
drug eluting balloon

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action