Post-market evaluation of safety & performance of Pipit-NC PTCA Balloon Dilatation Catheter in patients with stenotic coronary arteries during percutaneous coronary intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- 1. Device Success
Study Overview
Brief Summary
This is a prospective, observational, multi-center, single-arm, investigator-initiated study. A total of 87 consecutive patients who will be treated with at least one Pipit-NC PTCA balloon dilatation catheter during their index procedure (pre-dilation and/or post-dilation after stent deployment) will be enrolled according to routine clinical practice. A separate Pipit-NC PTCA balloon dilatation catheter will be used for pre-dilation, and post-dilation after stent deployment. The Pipit-NC PTCA balloon dilatation catheter will be used in multiple lesions, but data from the first treated lesion will be used for the analysis of primary and secondary outcomes.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient must be at least 18 years of age
- •Patient or a legally authorized representative must provide written informed consent prior to any study related procedure
- •Patient must agree not to participate in any other clinical study during hospitalisation for the index procedure
- •Target lesion(s) can be treated with Pipit-NC PTCA Balloon Dilatation Catheter as per the current IFU.
Exclusion Criteria
- •Patient not meeting any of the above inclusion criteria.
Outcomes
Primary Outcomes
1. Device Success
Time Frame: Baseline | (From the start to end of the interventional procedure)
2. Procedural success
Time Frame: Baseline | (From the start to end of the interventional procedure)
Secondary Outcomes
- Individual procedural parameters(- Coronary perforation)
- Safety endpoints(- All-cause mortality)