Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO) (NCT03209843) | Clinical Trial Compass
CompletedNot Applicable
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
France122 participantsStarted 2018-03-07
Plain-language summary
The objective of PERFECTO is to assess the reendothelialization at 3 months after successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES) by OFDI analysis. Designed as a multicentric, observational and prospective study which will be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia proliferation will be measured over the entire length of each stent implanted combining in a composite primary endpoint.
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:
* Successfully CTO revascularization by PCI with immediate post-PCI OFDI analysis
* 3 months follow-up with OFDI analysis of the recanalized coronary artery
* Aged 18 or over
* Written informed consent
Exclusion Criteria:
* Contraindication or impossibility to realize a safety coronary OFDI (severe tortuosities)
* Severe renal insufficiency (creatinine clearance \< 30 ml/min)
* Pregnancy or women with child-bearing potential
* Bacteriemia or septicemia
* Severe hemodynamic instability
* Severe coagulation disorders
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
1
Percentage of uncovered stent struts
Timeframe: 3 months
2
Percentage of malapposed stent struts
Timeframe: 3 months
3
Percentage of neointimal hyperplasia proliferation