CompletedNot Applicable

The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.

Turkey (Türkiye)100 participantsStarted 2023-01-01

Plain-language summary

The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Turkish citizen, * ≥18 years of age, * Has indication for a diagnostic coronarography according to Alvision™ Instruction for use, * Has signed and dated the informed consent. Exclusion Criteria: * Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter. * Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass * Participating in another medical device or pharmaceutical clinical trial

What they're measuring

Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system.

Timeframe: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure

Major adverse cardiovascular events (MACEs) and stroke associated with the use of diagnostic catheters until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure, whichever happens first:

Timeframe: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure

Trial details

NCT IDNCT05908422

SponsorAlvimedica

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-05-15

View on ClinicalTrials.gov More Coronary Artery Disease trials