Status:
COMPLETED
P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses
Lead Sponsor:
University Hospital, Saarland
Collaborating Sponsors:
B. Braun Melsungen AG
Conditions:
In-Stent Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon in the treatment of in-stent restenoses in native coronary arteries with reference diameters between 2....
Detailed Description
Background information: Stent deployment for the treatment of coronary artery stenoses has evolved as the standard treatment in nearly all types of coronary lesions over the past two decades.The init...
Eligibility Criteria
Inclusion
- Patient Related
- Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
- Patients eligible for coronary revascularization by means of PCI
- Age at least 18 years of age
- Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up
- Patients must agree to undergo the 6 months angiographic follow-up and the 1 and 3 year clinical follow-up Lesion Related
- In-stent restenosis or Mehran type III stenoses reaching ≤ 2 mm into the adjacent native vessel of a metal stent (including passive coatings, exclusive of active coatings), i.e., no recurrence in the native vessel adjacent to the stent, after stent deployment in a native coronary artery (reference vessel between 2.5 and 3.5 mm, lesion length ≤ 22 mm as angiographically documented)
- Diameter stenosis pre procedure must be either at least 70 % or 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris
- In the stent group, the target lesion must be treated with a single stent only (multiple stenting shifts the patient to the intention-to-treat group)
Exclusion
- Patient Related
- Patients with acute (\< 24 h) or recent (48 hours) myocardial infarction, unstable angina pectoris (Braunwald class 3)
- Clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP and/or fluid challenge)
- Patients with another coronary stent implanted previously into the target vessel
- Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
- Patients who had a cerebral stroke \< 6 months prior to the procedure
- Patient participates in other clinical trials involving any investigational device or drug
- Untreated hyperthyroidism
- Patient has presence or history of severe renal failure (GFR\<30ml/min) and is therefore not eligible for angiography. Patient's serum creatinine levels must be documented
- Post transplantation of any organ or immune suppressive medication
- Other disease to jeopardize follow-up (e.g., malignoma)
- Patients with any type of surgery during the week preceding the interventional procedure.
- Therapy with anticogulants
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00393315
Start Date
November 1 2005
End Date
December 1 2007
Last Update
June 30 2010
Active Locations (10)
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1
Kerckhoff-Clinic Bad Nauheim
Bad Nauheim, Germany, 61231
2
Unfallkrankenhaus Berlin
Berlin, Germany, 12683
3
Medizinische Klinik, Kardiologie, Charité - Hochschulmedizin Berlin
Berlin, Germany, 13353
4
Klinikum Darmstadt, Medizinische Klinik I
Darmstadt, Germany, 64283