Consistent CTO Trial

Chronic Total Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02227771
• Other study ID #: BSC-03
• Status: Active, not recruiting
• Phase: N/A
• First received: August 25, 2014
• Last updated: May 17, 2017
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: European Cardiovascular Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 215
• Est. completion date: December 2018
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Total Occlusion

Intervention

Device:
• Percutaneous coronary intervention

Locations

Country	Name	City	State
United Kingdom	Belfast Health & Social Care Trust	Belfast
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Edinburgh Royal Infirmary	Edinburgh
United Kingdom	Golden Jubilee, Glasgow	Glasgow
United Kingdom	Kings College, London	London
United Kingdom	London Chest Hospital,	London

Sponsors (2)

Lead Sponsor	Collaborator
European Cardiovascular Research Center	Ceric Sàrl

Country where clinical trial is conducted

United Kingdom, 

Outcome

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