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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02227771
Other study ID # BSC-03
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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