PIONEER Trial, A Prospective, Multicentre, Single arm, Non-Inferiority Clinical Trial to evaluate safety of Drug Eluting PTCA Balloons and CoCr coronary Stents mounted on a Drug Eluting Balloo

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

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 <100% stenosis.
4. Reference diameter between 2.0mm and 4.0mm and maximum lesion length of 26mm
5. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.

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 (<= 48 hours) myocardial infarction.
12. Patients with a contraindication to an emergent coronary bypass surgery.
13. Any individual who may refuse a blood transfusion.
14. Severe renal insufficiency (creatinine > 160 *mol/L or maximum flow declination rate (GFR < 50 ml/min).
15. Patients with intolerance or contraindication to the required medication (heparin, aspirin, clopidogrel and prasugrel, Paclitaxel).
16. Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the safety of the Paclitaxel Eluting Balloon (DEB) and Paclitaxel<br /><br>Eluting Balloon stent (DEBS) in patients with de novo coronary artery lesions<br /><br>by composite of Major Adverse Cardiac Event (MACE) rate at 6 months which must<br /><br>be <12%. MACE is defined as cardiac death, MI (Q-wave and non-Q-wave) and<br /><br>clinically driven target lesion revascularization (PCI and CABG)</p><br>

Secondary Outcome Measures