Computed Tomography Angiography Prediction Score for Percutaneous Revascularization of Chronic Total Occlusions (CT-RECTOR)

This study has been completed.
Sponsor:
Collaborators:
University of Giessen
University Hospital Erlangen
Institute of Cardiology, Warsaw, Poland
Information provided by (Responsible Party):
Prof. Dr. Christian W. Hamm, Kerckhoff Heart Center
ClinicalTrials.gov Identifier:
NCT02022878
First received: December 22, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing coronary angiography. The presence of an untreated CTO has been related to adverse clinical prognosis, both in stable angina and acute myocardial infarction, and is often associated with persistent symptomatic angina. Depending on their symptomatic and functional status as well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy combined with coronary revascularization.

The potential benefits of percutaneous coronary intervention (PCI) in CTO include symptom relief, improved left ventricular function, and potentially a survival advantage associated with success when compared with failed revascularization. Of note, marked advances in endovascular techniques and device technology have resulted in substantial improvements of procedural success rates of PCI in CTO.

In spite of these advances, the vast majority of patients with CTO are still being managed medically or referred for coronary bypass surgery rather than PCI. The most common reason for deferring PCI in patients with CTO appears to be the uncertainty of predicting the procedural outcome of percutaneous revascularization. Further barriers to attempting CTO by PCI include the difficulty of gauging the time required for the procedure and the use of resources.

The CT-RECTOR (Computed Tomography REgistry of Chronic Total Occlusion Revascularization) study was designed to evaluate the application of coronary computed tomography angiography (CTA) for the prediction of procedural outcome of PCI in CTO in an international patient population. The main purpose of this multicenter registry is to develop a noninvasive CTA-based prediction tool (CT-RECTOR Score) for grading CTO suitability for PCI.


Condition Intervention
Coronary Artery Disease
Procedure: PCI of CTO

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of Computed Tomography Angiography Prediction Score for Percutaneous Revascularization of Chronic Total Occlusions: Multicenter CT-RECTOR Registry

Resource links provided by NLM:


Further study details as provided by Kerckhoff Heart Center:

Primary Outcome Measures:
  • Successful guidewire crossing through CTO within 30 min [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
    Successful guidewire crossing through CTO within 30 min (defined as the time from initial insertion of the guidewire into the coronary lumen to the time it was successfully crossed through the lesion or was pulled out of the lumen because of unsuccessful guidewire crossing)


Secondary Outcome Measures:
  • Successful guidewire crossing through CTO and restoration of flow [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
    Successful guidewire crossing through CTO and restoration of flow (<50% residual stenosis and TIMI 2-3 flow)

  • Successful guidewire crossing through CTO with implantation of stent and restoration of flow [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
    Successful guidewire crossing through CTO with implantation of stent and restoration of flow (<50% residual stenosis and TIMI 2-3 flow) without severe coronary dissection or perforation


Enrollment: 229
Study Start Date: December 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Attempted PCI of CTO
Attempted PCI of CTO with preprocedural coronary CTA scan
Procedure: PCI of CTO

Detailed Description:

Coronary CTA has recently emerged as a valuable noninvasive tool to provide guidance during percutaneous treatment of CTO. The main advantages of coronary CTA in characterization of CTO include the 3-dimensional visualization of occlusion trajectory and morphology as well as the exact evaluation of calcifications. Despite this, and although prior single-center studies suggested a potential utility of individual coronary CTA-based CTO characteristics for predicting PCI, there has been no compiled prediction model for grading CTO suitability for PCI in a large cohort of patients.

The CT-RECTOR registry is a retrospective, multicenter observational study of patients undergoing preprocedural coronary CTA before attempted PCI of CTO between 2007 and 2013. The study was designed to enroll 250 consecutive patients at 4 high-volume cluster sites in 2 European countries. CT-RECTOR sites were chosen on the basis of adequate coronary CTA volume and PCI proficiency to reflect the state-of-the-art, ''real-life'' management of patients with CTO.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population consists of patients at multiple international centers undergoing preprocedural coronary CTA before attempted PCI of CTO between 2007 and 2013.

Criteria

Inclusion Criteria:

  • Patients referred for attempted PCI of CTO as part of their standard of care
  • Performance of coronary CTA with 64-detector rows or greater within 6 weeks before attempted PCI of CTO
  • Native vessel or bypass graft de novo or in-stent restenosis CTO
  • Angiographically defined CTO with TIMI flow 0 and estimated duration over 3 months (the duration of the occlusion was determined based on either a history of sudden chest pain, a previous myocardial infarction in the same target vessel territory, or the time between the diagnosis made from coronary angiography and subsequent PCI)

Exclusion Criteria:

  • Age <18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022878

Locations
Germany
Kerckhoff Heart Center
Bad Nauheim, Germany, 61231
University Clinic Erlangen
Erlangen, Germany, 91054
University Clinic Giessen and Marburg
Giessen, Germany, 35392
Poland
Institute of Cardiology
Warsaw, Poland, 04628
Sponsors and Collaborators
Kerckhoff Heart Center
University of Giessen
University Hospital Erlangen
Institute of Cardiology, Warsaw, Poland
Investigators
Principal Investigator: Christian W. Hamm, Prof. Dr. Kerckhoff Heart Center
  More Information

No publications provided

Responsible Party: Prof. Dr. Christian W. Hamm, Director, Cardiology Department, Kerckhoff Heart Center
ClinicalTrials.gov Identifier: NCT02022878     History of Changes
Other Study ID Numbers: NP-0021-106/1416/13
Study First Received: December 22, 2013
Last Updated: July 30, 2014
Health Authority: Germany: Ethics Commission
Poland: Ministry of Health

Keywords provided by Kerckhoff Heart Center:
Chronic total occlusion
Percutaneous coronary intervention
Coronary computed tomography angiography
Coronary angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014