Trials / Completed
CompletedNCT03209843
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Poitiers University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Chronic Total Occlusion of Coronary Artery
- Optical Coherence Tomography
- Ischemic Cardiomyopathy
- Neointimal Hyperplasia
- Stent Thrombosis
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Percutaneous recanalization of chronic total occlusion | Percutaneous recanalization of chronic total occlusion followed by immediate systematic coronary optical frequency domain imaging (OFDI) at inclusion. Intra-individual post stenting assessment of reendothelialization with a second coronary angiography with OFDI analysis at 3 months. |
Timeline
- Start date
- 2018-03-07
- Primary completion
- 2021-02-12
- Completion
- 2021-02-12
- First posted
- 2017-07-06
- Last updated
- 2021-04-14
Locations
7 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03209843. Inclusion in this directory is not an endorsement.