Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

Coronary Artery Stenosis Clinical Trial

Official title:

Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536180
• Other study ID #: ART-PTCA-02
• Status: Completed
• Start date: March 6, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: November 2023
• Source: Arthesys
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

• 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 be excluded as per IFU, Hospital standard of care and GCP. 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.

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Locations

Country	Name	City	State
France	Hopital Saint Louis	La Rochelle

Sponsors (1)

Lead Sponsor	Collaborator
Arthesys

Country where clinical trial is conducted

France, 

Outcome

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 procedure
Primary	Safety endpoint	Successful balloon dilatation without device related adverse event during the dilatation procedure	up to end of procedure
Secondary	Performance - Pre-dilatation	Residual stenosis < 50% and TIMI flow grade 3 (corelab assessment)	up to end of procedure
Secondary	Performance - post-dilatation	Angiographic success of the device defined as < 30% residual stenosis after angiography (corelab assessment)	up to end of procedure