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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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