Clinical trial NCT02227771: Consistent CTO Trial
Official title: CONventional Antegrade vs Sub-Intimal Synergy sTENTing in Chronic Total Occlusions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Total Occlusion
Lead sponsor: European Cardiovascular Research Center
Sponsor class: NETWORK
Collaborators: name: Ceric Sàrl
First posted: 2014-08-28
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who come to hospital for CTO and who met all the inclusion/eclusion criteria

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: The primary stent endpoint is 12-month target vessel failure (TVF) rate
timeFrame: 12 months
measure: The primary balloon endpoint is device procedural success
timeFrame: 1 month
Secondary outcomes:
measure: Target lesion revascularization (TLR) rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Target lesion failure (TLF) rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Target vessel revascularization (TVR) rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Target vessel failure (TVF) rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Myocardial infarction (MI, Q-wave and non-Q-wave) rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Cardiac death rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Non-cardiac death rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: All death rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Cardiac death or MI rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: All death or MI rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: All death/MI/TVR rate
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Stent thrombosis rate (by ARC definitions)
timeFrame: In hospital, 6 Months, 12 Months, 2 Years
measure: Angina, dyspnoea and quality of life scores
timeFrame: 12 Months
measure: In-stent and in-segment percent diameter stenosis (%DS)
timeFrame: Peri-procedural
measure: In-stent and in-segment minimum lumen diameter (MLD)
timeFrame: Peri-procedural
measure: Acute gain
timeFrame: Peri-procedural
measure: In-stent and in-segment %DS
timeFrame: 12-Months Post-Index Procedure
measure: In-segment late loss
timeFrame: 12-Months Post-Index Procedure
measure: In-stent and in-segment binary restenosis rate
timeFrame: 12-Months Post-Index Procedure
measure: In-stent and in-segment MLD
timeFrame: 12-Months Post-Index Procedure
measure: Incomplete apposition
timeFrame: Peri-procedural
measure: Stent, vessel and lumen areas and volumes
timeFrame: Peri-procedural
measure: Incomplete apposition
timeFrame: 12-Months Post-Index Procedure
measure: Aneurysm formation
timeFrame: 12-Months Post-Index Procedure
measure: Endothelial strut coverage percentage
timeFrame: 12-Months Post-Index Procedure
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health & Social Care Trust
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Golden Jubilee, Glasgow
city: London
country: United Kingdom
facility: London Chest Hospital,
city: London
country: United Kingdom
facility: Kings College, London
Study officials:
References:
citation: Walsh SJ, Hanratty CG, McEntegart M, Strange JW, Rigger J, Henriksen PA, Smith EJ, Wilson SJ, Hill JM, Mehmedbegovic Z, Chevalier B, Morice MC, Spratt JC. Intravascular Healing Is Not Affected by Approaches in Contemporary CTO PCI: The CONSISTENT CTO Study. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1448-1457. doi: 10.1016/j.jcin.2020.03.032.