A Clinical PeRformancE EVAluatIon of a new Medtronic Coronary Drug-Coated BaLloon Catheter<br>for the treatment of De Novo Lesions, In-Stent Restenosis and Small Vessel Disease in Coronary<br>Arteries; The PREVAIL study.

Completed

Conditions: coronary artery disease
coronary stenosis
10011082
10003216

Registration Number: NL-OMON48662

Lead Sponsor: Medtronic Trading NL BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
- Subject is an acceptable candidate for treatment with a Drug-Coated Coranary Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer*s Instructions for Use and the Declaration of Helsinki.
- Successful pre-dilatation of the (entire) target lesion(s) that will be treated with the investigational device. Success being documented by angiographic visual estimate of <30% residual stenosis of the target lesion and no major (> Grade B) flow-limiting dissection.
- Subject has a life expectancy >1 year in the Investigator*s opinion.
- Subject is willing and able to cooperate with study procedures and required follow up evaluations.
Angiographic Inclusion:
- The patient requires treatment of either:
A. At least a single lesion* amenable to treatment with the Medtronic Coronary Drug-Coated Balloon (* if two lesions can be treated by one Drug-Coated Balloon covering both lesions, it will be considered as a single target lesion).
OR
B. A maximum of four lesions in a maximum of 3 vessels. In case 3 vessels require to be treated, at least one should receive a non-DCB treatment, i.e. treatment with a Drug Eluting Stent (DES); this will be called a non-target lesion. Lesions (max. 3) treated with the DCB are considered target lesions.
Note: For subjects with a planned treatment of two to four lesions, the first lesion must be treated successfully and the subject must be clinically stable before treatment of the following one to three lesions are attempted. The lesion(s) in each vessel that is (/are) planned to be treated with the DES should be treated first.
- Target lesion(s) must be * 25 mm in length.
- Target lesion(s) must have a stenosis of * 50% and < 100%.
- Target lesion(s) to be treated with the investigational device must have an RVD between 2.0 and 4.0 mm in diameter.
- Target vessel(s) must have a thrombolysis in myocardial infarction (TIMI) flow * 2.
Note: Measurements may be made by careful visual estimate, on-line QCA, IVUS, or OCT

Exclusion Criteria

- Known hypersensitivity or contraindication to aspirin; heparin; bivalirudin; clopidogrel; prasugrel; ticagelor and structurally related compounds; or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative.
- Platelet count < 100,000 cells/mm³ (i.e. 100 x 109/L) or > 700,000 cells/mm³ (i.e. 700 x 109/L), or a white blood cell (WBC) count < 3,000 cells/mm³ within 7 days prior to index procedure.
- Serum creatinine level > 2.5 mg/dl (i.e. 221 *mol/L) within 7 days prior to index procedure
- Evidence of an Acute Myocardial Infarction within the previous 72 hours of the study procedure.
- Planned treatment of the left main coronary artery, internal mammary artery, aorto-ostial, and sapheneous vein grafts with the investigational device.
- Planned treatment of more than one lesion in one target vessel, or more than two lesions in two target vessels.
- Planned treatment involves a bifurcation.
- Previous percutaneous coronary intervention (PCI) of the target vessels(s)
- within 3 months prior to the procedure for In-Stent Restenosis;
- within 9 months prior to the procedure for de novo lesions.
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 6 months post-procedure.
- During the index procedure, the target lesion(s) require(s) treatment with a cutting/scoring balloon, atherectomy, laser, or thrombectomy procedure.
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months (any prior stroke or TIA, if prasugrel is used).
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Any previous treatment of the target vessel for restenosis, including brachytherapy.
- Pregnant or breast-feeding woman.
- Documented left ventricular ejection fraction (LVEF) <30% at the most recent evaluation, within 3 months.
Angiographic Exclusion Criteria
- Target lesion(s) is/are located in a bypass graft (including but not limited to saphenous vein graft or a left/right internal mammary artery.
- Target vessel(s) has/have other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.
- Target vessel(s) has/have evidence of thrombus.
- Target vessel(s) is/are excessively tortuous (any bend >90º to reach the target lesion).
- Target lesion(s) has/have any of the following characteristics:
a. Lesion location is aorto-ostial, an unprotected left main lesion, or within 5mm of the origin of the left anterior descending (LAD) or left circumflex (LCX)
b. Involves a side branch >2.0mm in diameter
c. Is at a >45º bend in the vessel
d. Is severely calcified
- Unprotected left main coronary artery disease is present (an obstruction greater than 50% in the left main coronary artery).
- Lesion that is planned to be treated is longer than 25 mm in length or RVD is smaller than 2 mm.