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Chronic Total OcclusionNCT02227771

Consistent CTO Trial

An observational study of Chronic Total Occlusion, run by European Cardiovascular Research Center at 6 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Total Occlusion
What is being tested?
Percutaneous coronary intervention
Type of treatment
Medical device
How many people
215 participants
Where
6 sitesUnited Kingdom
Study dates
Dec 2014to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 22Show fewer
  • 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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • Belfast Health & Social Care Trust

    Belfast, BT9 7AB

  • Bristol Royal Infirmary

    Bristol, BS2 8HW

  • Edinburgh Royal Infirmary

    Edinburgh, EH16 4SA

  • Golden Jubilee, Glasgow

    Glasgow, G81 4DY

  • London Chest Hospital,

    London, E2 9JX

  • Kings College, London

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Percutaneous coronary intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary interventionDevice

Study groups in NCT02227771
Study groupRoleWhat they receive
Patient with chronic total occlusionNot described
Receives: Device: Percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 1 month

Secondary outcomes (25)

  1. Target lesion revascularization (TLR) rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  2. Target lesion failure (TLF) rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  3. Target vessel revascularization (TVR) rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  4. Target vessel failure (TVF) rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  5. Myocardial infarction (MI, Q-wave and non-Q-wave) rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  6. Cardiac death rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  7. Non-cardiac death rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  8. All death rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  9. Cardiac death or MI rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  10. All death or MI rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  11. All death/MI/TVR rate

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  12. Stent thrombosis rate (by ARC definitions)

    Measured: In hospital, 6 Months, 12 Months, 2 Years

  13. Angina, dyspnoea and quality of life scores

    Measured: 12 Months

  14. In-stent and in-segment percent diameter stenosis (%DS)

    Measured: Peri-procedural

  15. In-stent and in-segment minimum lumen diameter (MLD)

    Measured: Peri-procedural

  16. Acute gain

    Measured: Peri-procedural

  17. In-stent and in-segment %DS

    Measured: 12-Months Post-Index Procedure

  18. In-segment late loss

    Measured: 12-Months Post-Index Procedure

  19. In-stent and in-segment binary restenosis rate

    Measured: 12-Months Post-Index Procedure

  20. In-stent and in-segment MLD

    Measured: 12-Months Post-Index Procedure

  21. Incomplete apposition

    Measured: Peri-procedural

  22. Stent, vessel and lumen areas and volumes

    Measured: Peri-procedural

  23. Incomplete apposition

    Measured: 12-Months Post-Index Procedure

  24. Aneurysm formation

    Measured: 12-Months Post-Index Procedure

  25. Endothelial strut coverage percentage

    Measured: 12-Months Post-Index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion31 Dec 2016
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
215 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227771
Sponsor's protocol ID
BSC-03
Status last verified
May 2017
First submitted
25 Aug 2014
Last updated
18 May 2017
Results posted
No

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.

    PubMed 32553333

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Total Occlusion, run by European Cardiovascular Research Center at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary stent endpoint is 12-month target vessel failure (TVF) rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227771, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.

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