Status:
COMPLETED
Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH - ISR II)
Lead Sponsor:
University Hospital, Saarland
Conditions:
Coronary Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The PACCOCATH ISR II 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.
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 (IS...
Eligibility Criteria
Inclusion
- 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 \< 30 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00409981
Start Date
July 1 2004
End Date
June 1 2006
Last Update
December 12 2006
Active Locations (5)
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1
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg / Saar, Saarland, Germany, 66421
2
Kardiologie, Campus Mitte, Charite
Berlin, Germany, 10117
3
Kardiologie, Campus Virchow-Klinikum, Charite
Berlin, Germany, 13353
4
Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie
Freiburg im Breisgau, Germany, 79106