Chronic Total Occlusion of Coronary ArteryPERFECTONCT03209843
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
A study testing Percutaneous recanalization of chronic total occlusion in people with Chronic Total Occlusion of Coronary Artery and Optical Coherence Tomography, run by Poitiers University Hospital at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Optical Coherence Tomography, Ischemic Cardiomyopathy
- What is being tested?
- Percutaneous recanalization of chronic total occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Mar 2018to 12 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
GHM de Grenoble
Grenoble, 38000
Bressollette
Nantes
CHU de Nimes
Nîmes, 30000
CHU Poitiers
Poitiers, 86021
Institut A.Tzanck
Saint-Laurent-du-Var, 06000
CHU de Toulouse
Toulouse, 31000
About this study
Official title: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
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
- Being tested
- Percutaneous recanalization of chronic total occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous recanalization of chronic total occlusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Successfully CTO recanalization | Other | Not described Receives: Procedure: Percutaneous recanalization of chronic total occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of uncovered stent struts
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number uncovered struts x 100)/total number of struts.
Measured: 3 months
Percentage of malapposed stent struts
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number of malapposed struts x 100)/total number of struts.
Measured: 3 months
Percentage of neointimal hyperplasia proliferation
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. [(minimal stent area - minimal lumen area)/minimal stent area]x100.
Measured: 3 months
Minimal lumen area
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Measured: 3 months
Minimal lumen diameter
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted
Measured: 3 months
Thrombus
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Measured: 3 months
Edge dissection
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Measured: 3 months
Secondary outcomes (5)
Relevancy of immediate post-PCI OFDI analysis
To estimate the percentage of patients in whom the post-stenting OFDI analysis will reveal a suboptimal result of angioplasty whereas final angiography was considered optimal, as assessed by the presence of one or more of the following criteria:
- Dissection or thrombus.
- Residual stenosis.
- Stent malapposition defined by at least one malapposed strut.
- Residual stenosis.
Measured: Day one
Impact of the technique employed for CTO revascularization on the reendothelialization
Comparison of primary composite endpoint between different way of recanalization:
- Anterograde.
- Retrograde.
- Dissection/re-entry.
Measured: 3 months
One year clinical follow-up
Each participating center will perform one year after CTO PCI a clinical evaluation of all patients included. This could be established directly with the subject during medical follow-up or indirectly via family doctor. Standardized questionnaire will be provided at the end of the e-case report form (CRF). Occurrence of major adverse cardiac events (myocardial infarction, death, stroke), sudden death, hospitalization for cardiac disease and severe hemorrhage will be recorded. Any new coronary arteriography will be noticed, as well as any PCI or coronary artery bypass graft (CABG) during this one-year follow-up.
- Death all-cause
- Myocardial infarction
- Stroke
- Sudden death
- Hospitalization for cardiac cause
- Severe hemorrhage
Measured: One year
Angina
About symptoms, the Canadian Cardiovascular Society (CCS) grading system and New York Heart Association functional classification will be used to assess respectively exertion-induced angina and dyspnea, and compared to symptoms recorded before CTO revascularization.
Measured: One year
Dyspnea
About symptoms, the Canadian Cardiovascular Society (CCS) grading system and New York Heart Association functional classification will be used to assess respectively exertion-induced angina and dyspnea, and compared to symptoms recorded before CTO revascularization.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start7 Mar 2018
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Levesque, MD, Principal investigator, University Hospital of Poitiers, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209843
- Sponsor's protocol ID
- PERFECTO
- Acronym
- PERFECTO
- Status last verified
- Apr 2021
- First submitted
- 20 Jun 2017
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Levesque S, Faurie B, Lattuca B, Lemoine J, Pitchecanin G, Motreff P, Bressollette E, Ragot S, Bouleti C, Christiaens LP. Optical Coherence Tomography to Better Assess Chronic Total Occlusion Percutaneous Intervention Results: The PERFECTO Study. JACC Adv. 2025 Oct;4(10 Pt 2):102125. doi: 10.1016/j.jacadv.2025.102125. Epub 2025 Sep 9.
PubMed 40930013
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
- ClinicalTrials.gov ID
- NCT03209843
- Acronym / sponsor ID
- PERFECTO / PERFECTO
- Conditions
- Chronic Total Occlusion of Coronary Artery, Optical Coherence Tomography, Ischemic Cardiomyopathy, Neointimal Hyperplasia, Stent Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Successfully CTO recanalization | Other | Procedure: Percutaneous recanalization of chronic total occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous recanalization of chronic total occlusionPercutaneous 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. | Procedure or surgery | Successfully CTO recanalization |
Primary outcome
Percentage of uncovered stent struts
Time frame: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number uncovered struts x 100)/total number of struts.
Percentage of malapposed stent struts
Time frame: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number of malapposed struts x 100)/total number of struts.
Percentage of neointimal hyperplasia proliferation
Time frame: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. [(minimal stent area - minimal lumen area)/minimal stent area]x100.
Minimal lumen area
Time frame: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Minimal lumen diameter
Time frame: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted
Thrombus
Time frame: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Edge dissection
Time frame: 3 months
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
5 secondary outcomes
Relevancy of immediate post-PCI OFDI analysis
Time frame: Day one
Impact of the technique employed for CTO revascularization on the reendothelialization
Time frame: 3 months
One year clinical follow-up
Time frame: One year
Angina
Time frame: One year
Dyspnea
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 40930013Levesque S, Faurie B, Lattuca B, Lemoine J, Pitchecanin G, Motreff P, Bressollette E, Ragot S, Bouleti C, Christiaens LP. Optical Coherence Tomography to Better Assess Chronic Total Occlusion Percutaneous Intervention Results: The PERFECTO Study. JACC Adv. 2025 Oct;4(10 Pt 2):102125. doi: 10.1016/j.jacadv.2025.102125. Epub 2025 Sep 9.
Related trials for Chronic Total Occlusion of Coronary Artery
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
RecruitingObservational study
Prospective Global Registry for the Study of Chronic Total Occlusion Intervention
Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien Levesque, MD principal investigator
University Hospital of Poitiers, Department of Cardiology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous recanalization of chronic total occlusion in people with Chronic Total Occlusion of Coronary Artery and Optical Coherence Tomography, run by Poitiers University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of uncovered stent struts (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.