Consistent CTO Trial

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy stent should minimize the risk of late aneurysm formation and potential clinical complications but not at the cost of enhanced efficacy.

Official Title
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CONventional Antegrade vs Sub-Intimal Synergy sTENTing in Chronic Total Occlusions

Conditions
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Chronic Total Occlusion

Intervention / Treatment
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* Device: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient >18 years old Females of childbearing potential with a negative pregnancy test Presence of Chronic Total Occlusion (CTO) that is known or presumed to be of at least 3 months in duration Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent Attempt to implant at least one Synergy II stent has been made Exclusion Criteria: Acute myocardial infarction with ongoing ST-elevation Cardiogenic shock Left ventricular ejection fraction <20% Subject has one of the following (as assessed prior to the index procedure): Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.) Planned procedure that may cause non-compliance with the protocol or confound data interpretation Subject is treated by dialysis or has a baseline serum creatinine level >220 μmol/L (2.5 mg/dL) Known allergy to to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin) Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint OR subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure Need for ongoing long-term anticoagulation Subject has received an organ transplant or is on a waiting list for an organ transplant Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure Planned CABG after the index procedure Subject previously treated at any time with intravascular brachytherapy Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3 Subject has a white blood cell (WBC) count < 3,000 cells/mm3 Subject has documented or suspected liver disease, including laboratory evidence of hepatitis Subject has a clinically significant bleeding diathesis or coagulopathy or will refuse blood transfusions Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding Subject has severe symptomatic heart failure (i.e., NYHA class IV) Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure) Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with chronic total occlusion<br> | Device: Percutaneous coronary intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary stent endpoint is 12-month target vessel failure (TVF) rate | The primary stent endpoint is 12-month target vessel failure (TVF) rate, defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or cardiac death. | 12 months | 
| The primary balloon endpoint is device procedural success | Successful delivery of the Emerge Coronary Dilatation catherter across the lesion and Successful inflation and removal of the Emerge Coronary Dilatation catherter with absences of clinically significant vessel perforation or flow limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrythmias requiring medical treatment or device intervention following dilatation with Emerge balloon and Achievment of final TIMLI 3 flow for the target lesion at the conclusion of the index procedure. The primary balloon endpoint will be evaluated in patients where an attempt to use an Emerge Coronary Dilatation catherter is made. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion revascularization (TLR) rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Target lesion failure (TLF) rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Target vessel revascularization (TVR) rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Target vessel failure (TVF) rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Myocardial infarction (MI, Q-wave and non-Q-wave) rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Cardiac death rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Non-cardiac death rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| All death rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Cardiac death or MI rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| All death or MI rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| All death/MI/TVR rate |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Stent thrombosis rate (by ARC definitions) |  | In hospital, 6 Months, 12 Months, 2 Years | 
| Angina, dyspnoea and quality of life scores |  | 12 Months | 
| In-stent and in-segment percent diameter stenosis (%DS) |  | Peri-procedural | 
| In-stent and in-segment minimum lumen diameter (MLD) |  | Peri-procedural | 
| Acute gain |  | Peri-procedural | 
| In-stent and in-segment %DS |  | 12-Months Post-Index Procedure | 
| In-segment late loss |  | 12-Months Post-Index Procedure | 
| In-stent and in-segment binary restenosis rate |  | 12-Months Post-Index Procedure | 
| In-stent and in-segment MLD |  | 12-Months Post-Index Procedure | 
| Incomplete apposition |  | Peri-procedural | 
| Stent, vessel and lumen areas and volumes |  | Peri-procedural | 
| Incomplete apposition |  | 12-Months Post-Index Procedure | 
| Aneurysm formation |  | 12-Months Post-Index Procedure | 
| Endothelial strut coverage percentage |  | 12-Months Post-Index Procedure |