Coronary Artery Stenosis Clinical Trial
Official title:
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family
NCT number | NCT05232565 |
Other study ID # | ART-PTCA-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 29, 2022 |
Est. completion date | July 15, 2023 |
Verified date | July 2023 |
Source | Arthesys |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 15, 2023 |
Est. primary completion date | June 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication - Patient >18 years - Patient who understands the trial requirements and the treatment procedures and provides written informed consent Exclusion Criteria: - Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Saint Louis | La Rochelle |
Lead Sponsor | Collaborator |
---|---|
Arthesys |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy endpoint | Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter | Up to end of PTCA procedure | |
Primary | Safety endpoint | Successful balloon dilatation without device related adverse event during the dilatation procedure | Up to end of PTCA procedure | |
Secondary | Performance - pre-dilatation | Residual stenosis < 50% and TIMI flow grade 3 | Up to end of PTCA procedure | |
Secondary | Performance - post-dilatation | Angiographic success of the device defined as <30% residual stenosis after angiography | Up to end of PTCA procedure |
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