Coronary artery disease stenosis
Conditions
Interventions
Patients are treated by a PTCA procedure where a Paclitaxel Eluting Balloon
mounted with a Cobalt Chromium stent (DEBS) and/or Paclitaxel Eluting Balloon
(DEB) is used to treat stenotic lesions.
Whi
Sponsors
Blue Medical Devices BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia 2. Patients who are eligible for coronary revascularization (percutaneous angioplasty and/or CABG). 3. Patients with up to two de novo lesion in a native coronary artery >50% and
Exclusion criteria
Exclusion criteria: 1. Patients under the age of 18 or unable to give informed consent. 2. Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up. 3. Patients who previously participated in this study. 4. Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. 5. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.). 6. Patients treated with drug eluting stent(s) in the target vessel less than 12 months prior to the index procedure 7. Patients with a previous stent in the target lesion (in-stent Restenosis) 8. Patients with angiographic evidence of severe calcification of the target lesion. 9. Angiographic evidence of presence of thrombus in the target vessel 10. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study. 11. Patients with recent ( 160 *mol/L or maximum flow declination rate (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of the Paclitaxel Eluting Balloon (DEB) and Paclitaxel Eluting Balloon stent (DEBS) in patients with de novo coronary artery lesions by composite of Major Adverse Cardiac Event (MACE) rate at 6 months which must be | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device Success: The ability of the Drug Eluting Balloon (DEB) to be delivered at the target lesion , to be able to dilate and retrieve the system or, the ability of the Drug Eluting Balloon Stent (DEBS) to be delivered at the target lesion, to be able to deploy the stent and retrieve the delivery system. 2. Lesion treatment success is defined as | — |
Countries
Netherlands
Outcome results
None listed