NC Xperience Post-Market Clinical Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 59
- Locations
- 3
- Primary Endpoint
- Safety Endpoint. Freedom from Target Lesion Failure
Study Overview
Brief Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of NC Xperience to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with NC Xperience .
Detailed Description
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the NC Xperience in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient treated with NC Xperience according to routine hospital practice and following instructions for use
- •Informed consent signed
Exclusion Criteria
- •Not meet inclusion criteria
Outcomes
Primary Outcomes
Safety Endpoint. Freedom from Target Lesion Failure
Time Frame: 7 days
Freedom from composite of cardiac death, myocardial infarction (MI) and Target Lesion Revascularization (TLR)
Secondary Outcomes
- Efficacy Endpoint. freedom from Target Lesion Failure(7 days)
- Freedom from Hypotube rupture(During PCI)
- Freedom from Balloon rupture(During percutaneous coronary intervention (PCI))
- Freedom from Complicated withdrawal(During PCI)
- Freedom from Coronary perforation(During PCI)
- Freedom from Coronary dissection >C(During PCI)
- Freedom from No reflow(During PCI)
- Freedom from Coronary thrombosis(During PCI)