Status:
UNKNOWN
Consistent CTO Trial
Lead Sponsor:
European Cardiovascular Research Center
Collaborating Sponsors:
Ceric Sàrl
Conditions:
Chronic Total Occlusion
Eligibility:
All Genders
18+ years
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 th...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT02227771
Start Date
December 1 2014
End Date
December 1 2018
Last Update
May 18 2017
Active Locations (6)
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1
Belfast Health & Social Care Trust
Belfast, United Kingdom, BT9 7AB
2
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
3
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
4
Golden Jubilee, Glasgow
Glasgow, United Kingdom, G81 4DY