Coronary De-novo Stenoses Clinical Trial
— PEPCAD-DEBonlyOfficial title:
Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon
| NCT number | NCT01084408 |
| Other study ID # | Pac 14 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | March 1, 2010 |
| Est. completion date | March 1, 2013 |
| Verified date | March 2021 |
| Source | Universität des Saarlandes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.
| Status | Terminated |
| Enrollment | 90 |
| Est. completion date | March 1, 2013 |
| Est. primary completion date | March 1, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | Inclusion Criteria: - Age > 18 years - Clinical evidence of stable or unstable angina or a positive functional study - Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types) - Diameter stenosis > 70% (visual estimate) - Vessel diameter 2.5 - 3.5 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 - Patient's and treating physician's 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% - Visible thrombus proximal to the lesion - Expection that treatment with devices other than PTCA will be required for this lesion. - Stenosis is within a bypass graft - Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, 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, cause 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). - Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment) - Chronic renal insufficiency with serum creatinine > 2.0 mg% - 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 which may inter-fere with the interpretation of results of this study |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Medizinisches Versorgungszentrum | Hamburg | |
| Germany | Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann | Postdam | Brandenburg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Saarland |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Late lumen loss | Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab. | 6 months | |
| Secondary | Thrombotic occlusion of the target lesion | 30 days, 6, 12, 24, 60 months | ||
| Secondary | Revascularization of the target lesion | 30 days, 6, 12, 24, 60 months | ||
| Secondary | Myocardial infarction | 30 days, 6, 12, 24, 60 months | ||
| Secondary | Death | 30 days, 6, 12, 24, 60 months | ||
| Secondary | Combined clinical endpoint (MACE) | consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death | 30 days, 6, 12, 24, 60 months |