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Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival (SYNTAXES)

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ClinicalTrials.gov Identifier: NCT03417050
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Stuart Head, Erasmus Medical Center

Tracking Information
First Submitted Date January 25, 2018
First Posted Date January 31, 2018
Last Update Posted Date July 24, 2018
Actual Study Start Date December 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2018)
Long-term survival status [ Time Frame: 10-year ]
All-cause death
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03417050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 25, 2018)
Cause of death [ Time Frame: 10-year ]
Cause-specific death, separated in cardiovascular and non-cardiovascular death with specific causes for cardiovascular deaths.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival
Official Title Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival
Brief Summary An investigator-driven, retrospective study to compare long-term survival-data (10-year follow-up) of patients with coronary artery disease (CAD), previously enrolled in the SYNTAX trial, who were randomized to percutaneous coronary intervention (PCI) using a paclitaxel (TAXUS) drug-eluting-stent (DES) or coronary artery bypass grafting (CABG).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients enrolled in the SYNTAX trial and registries had to be diagnosed with three-vessel (3VD) or left main (LM) coronary artery disease. The vessels (diameter ≥1.5 mm and significant stenosis > 50%) deemed important to revascularize were determined by the Heart Team prior to randomization. The group of 3VD consists of patients with significant stenosis in vessels supplying all three major epicardial territories in absence of LM disease, as determined by the site investigators. The group of patients with LM disease consists of patients with a significant stenosis of the left main coronary artery, irrespective of additional vessel disease.
Condition Coronary Artery Disease
Intervention Other: No intervention will take place for this retrospective and observational study.
No intervention will take place for this retrospective and observational study.
Study Groups/Cohorts
  • Randomized CABG patients
    Patients which were randomized to undergo CABG.
    Intervention: Other: No intervention will take place for this retrospective and observational study.
  • Randomized PCI patients
    Patients which were randomized to undergo PCI.
    Intervention: Other: No intervention will take place for this retrospective and observational study.
  • Registry CABG
    Patients for whom only one treatment option was suitable were included into a parallel, nested registry: the CABG registry for PCI-ineligible patients.
    Intervention: Other: No intervention will take place for this retrospective and observational study.
  • Registry PCI
    Patients for whom only one treatment option was suitable were included into a parallel, nested registry: the PCI registry for CABG-ineligible patients.
    Intervention: Other: No intervention will take place for this retrospective and observational study.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Actual Enrollment
 (submitted: January 25, 2018)
2636
Original Actual Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria Patients which have previously been enrolled in the SYNTAX trial (randomized and registry patients)
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03417050
Other Study ID Numbers MEC-2016-716
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Stuart Head, Erasmus Medical Center
Study Sponsor Erasmus Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: A. Pieter Kappetein, MD, PhD Erasmus Medical Center
Principal Investigator: Friedrick W. Mohr, MD, PhD German Heart Center, Leipzig, Germany
Principal Investigator: Patrick W.J.C. Serruys, MD, PhD Imperial College London
Principal Investigator: Michael J. Mack, MD, PhD Baylor Scott & White Health, Plano, TX, United States
Principal Investigator: David R. Holmes, MD Mayo Clinic, Rochester, MN, United States
Principal Investigator: Marie-Claude Morice, MD ICPS Ramsay-Generale de Sante, Massy, France
Principal Investigator: Piroze M. Davierwala, MD German Heart Center, Leipzig, Germany
Principal Investigator: Stuart J. Head, MD, PhD Erasmus Medical Center
Study Chair: Daniel J.F.M. Thuijs, MD Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date July 2018