A Prospective Study to evaluate the Safety and Performance of PROTégé -Drug-Eluting Balloon in Treating real world Coronary ArTery Disease patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 30
- Primary Endpoint
- The primary endpoint of the study is TLF rate through 12 months.
Study Overview
Brief Summary
Prospective, Single-arm, Multi-center, Post-marketing, Observational, Open label Registry to collect data on safety and efficacy of (Paclitaxel Coated Coronary Balloon Dilatation Catheter) used during routine clinical practice in all comers’ CAD population (including Subjects with stable angina, unstable angina or silent ischemia and acute coronary syndromes) undergoing Percutaneous treatment with Drug Eluting/Coating Balloon. All the data of the Subjects’ demographic characteristics, co-morbidities and laboratory parameters details will be collected from medical records during patient procedure visit and follow-up visit, and all clinical characteristics will be recorded in the case record form (CRF) or e-CRF
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age above 18 years
- •Patients with symptomatic coronary artery disease (including those with acute coronary syndromes (except Acute STEMI) or Chronic Coronary Syndromes) with either symptoms and/or ischemia.
- •The patient must be able to understand and provide informed consent and comply with all study procedures.
- •Angiographic inclusion criteria
- •Greater than or equal to 70% target lesion stenosis in LAD, LCX, or RCA (or branches) which after successful pre-dilatation has a residual stenosis, less than or equal to 30% and no dissection greater than Type C (NHLBI guidelines) (pre-dilatation permitted with SC or NC balloon catheter, cutting/scoring balloon, rotational/orbital atherectomy, IVL or laser)
- •The target vessel reference diameter must be between 2.0 and 4.5 mm.
Exclusion Criteria
- •LVEF less than or equal to 30%
- •Known contraindication or hypersensitivity to paclitaxel, and/or to any anti-thrombotic and anti-platelet class of drugs.
- •Allergy to imaging contrast media which cannot be adequately pre-medicated.
- •Patient undergoing planned surgery within 3 months with the necessity to stop DAPT.
- •Patient is pregnant or nursing lactating women.
- •Patient is recipients of a heart transplant.
- •Patient is unwilling or unable to give follow-up till study completion.
- •Currently participating in another trial.
- •Life Expectancy less than 1 year.
- •Angiographic exclusion criteria:
- •Target lesion is in the left main coronary artery.
- •Flow limiting target vessel thrombus.
- •Vessel dissection requiring bailout stenting (in the case of bailout stenting only follow-up will be excluded.
- •We won’t follow up the patient with bailout stenting, but the baseline and procedural data will be collected for the patient as that will provide us the frequency of vessel injury during the DCB/DEB angioplasty procedure).
Outcomes
Primary Outcomes
The primary endpoint of the study is TLF rate through 12 months.
Time Frame: 12 Month
(The primary endpoint of the study is a composite endpoint. Cumulative TLF is defined as events of Cardiac Deaths, Target vessel-related Myocardial Infarction, and clinically driven Target Lesion Revascularization at 12 months after the index procedure.)
Time Frame: 12 Month
Secondary Outcomes
- 1. Device success - Defined as the ability of the study device to be delivered, dilated and retrieved from the target lesion.(2. Procedural success Defined as technical and angiographic success in the absence of major adverse events during hospitalization.)
Investigators
Dr V Surya Prakasa Rao
CARE Hospitals