Clinical Trials Logo

Clinical Trial Summary

Coronary arteries are in charge of oxygen supply for the myocardium. When coronary arteries develop stenosis the coronary blood flow (i.e. oxygen flow) is reduced. Chronic total occlusion (CTO) is the extreme evolution of a coronary stenosis, which ends up to a total vessel closure. Percutaneous coronary intervention (PCI) is the main treatment for chronic occlusions. The principle of this treatment is to implant a stent covering the whole segment of occlusion and allowing the blood to perfuse the myocardium antegradely and not retrogradely via the collateral(s). This angioplasty and stent implantation requires a dual antiplatelet therapy (aspirin associated with clopidogrel) to prevent a new thrombosis within the newly placed coronary stent. Following the development of coronary stent (and particularly drug eluting coronary stent) new thrombosis within the implanted coronary scaffold have emerged. Dual antiplatelet therapy (DAPT) (compared to single antiplatelet therapy or anticoagulant) and initially prolonged DAPT (12 months) has offered a preventive treatment for stent thrombosis after PCI. PCI treatment for CTOs continues to increase in France and around the world, while no dedicated study has been proposed so far regarding DAPT duration. Therefore, the general European recommendations for DAPT in chronic coronary syndrome management guidelines should be applied even though the CTO poses specific technical challenges (long and multiple stenting length for example). Even if 6 months DAPT is recommended as routine duration in chronic coronary syndrome (CCS), longer DAPT (12 months) is possible in this setting. However, the optimal duration of DAPT is not clearly demonstrated on an individual basis and each physician must adapt the DAPT duration for each single patient. A so called "ischemic / bleeding balance "guides the duration of DAPT. This study would be the first randomized protocol to clarify the efficacy and safety of a shorter DAPT duration in the specific context of CTO PCI. It is conceivable that the technical advances which have made it possible to reduce the duration of DAPT to up to 1 month, in the cases of patients at high risk of bleeding for example, could be applicable to CTO PCI. Therefore, reducing the DAPT to 1 month, in the setting of CTO PCI, could reduce the haemorrhagic risk which should be proportional to the duration of the DAPT. Moreover, the invesitgators will evaluate the safety of short DAPT in terms of ischemic events during follow-up.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06175377
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact Pierre DEHARO, Dr
Phone 04 91 48 59 97
Email pierre.deharo@ap-hm.fr
Status Not yet recruiting
Phase N/A
Start date March 30, 2024
Completion date September 30, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05111496 - Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)
Not yet recruiting NCT05440084 - Impact of CTO PCI (Chronic Total Occlusion Percutaneous Intervention) on Regular Physical Activity
Withdrawn NCT04059536 - Registry Study to Evaluate the Performance and Safety of Roxwood Medical Catheters in Arteries of Participants With a Stenotic Lesion or Chronic Total Occlusion (CTO)
Completed NCT05158686 - Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty
Completed NCT03988166 - Chronic Total Occlusion Percutaneous Coronary Intervention Study N/A
Not yet recruiting NCT05632653 - CTO-PCI in Heart Failure Patients N/A
Recruiting NCT03563989 - STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion N/A
Recruiting NCT04710342 - Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions N/A
Not yet recruiting NCT06358508 - Sapphire 3 CTO Study N/A
Completed NCT01246505 - Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions Phase 3
Recruiting NCT05614180 - Chronic Total Occlusive Lesions CMR Study
Completed NCT04226326 - Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion N/A
Recruiting NCT04533633 - German Epicardial Collateral CTO Registry
Recruiting NCT04650139 - Coronary Interventions Ulm - Coronary Chronic Total Occlusions
Recruiting NCT06137521 - Risk Factors and Outcomes in Coronary Chronic Total Occlusion
Completed NCT02358629 - A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO). N/A
Completed NCT00670436 - The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions Phase 2
Completed NCT04862559 - A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions N/A
Active, not recruiting NCT02227771 - Consistent CTO Trial N/A
Recruiting NCT05458999 - Decreasing Patient Anxiety During Revascularization of Chronic Total Coronary Occlusions Using Virtual Reality Glasses. N/A