Consistent CTO Trial

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Total Occlusion
• Intervention / Treatment: Device: Percutaneous coronary intervention

• Study Type: Observational
• Enrollment (Anticipated): 215

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast Health & Social care Trust
  • Bristol, United Kingdom, BS2 8HW
    • Bristol Royal Infirmary
  • Edinburgh, United Kingdom, EH16 4SA
    • Edinburgh Royal Infirmary
  • Glasgow, United Kingdom, G81 4DY
    • Golden Jubilee, Glasgow
  • London, United Kingdom, E2 9JX
    • London Chest Hospital,
  • London, United Kingdom, SE5 9RS
    • Kings College, London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who come to hospital for CTO and who met all the inclusion/eclusion criteria

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with chronic total occlusion	Device: Percutaneous coronary intervention

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: European Cardiovascular Research Center
• Collaborators: Ceric Sàrl

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BSC-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No