Consistent CTO Trial

NCT02227771 | Unknown

• 1 other identifier: BSC-03
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 6

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.

Conditions

Chronic Total Occlusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (25)

• 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

Study Arms (1)

Patient with chronic total occlusion

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

Patient with chronic total occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Cardiovascular Research Center: lead
• Ceric Sàrl: collaborator

Study Sites (6)

Belfast Health & Social Care Trust

Belfast, BT9 7AB, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Golden Jubilee, Glasgow

Glasgow, G81 4DY, United Kingdom

Location

London Chest Hospital,

London, E2 9JX, United Kingdom

Location

Kings College, London

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32553333 DERIVED

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 28, 2014
• Study Start: December 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 1, 2018
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

GB (6)