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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

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).

Condition or disease Intervention/treatment
Coronary Artery Disease Other: No intervention will take place for this retrospective and observational study.

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Study Type : Observational
Actual Enrollment : 2636 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival
Actual Study Start Date : December 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Randomized CABG patients
Patients which were randomized to undergo CABG.
Other: No intervention will take place for this retrospective and observational study.
No intervention will take place for this retrospective and observational study.

Randomized PCI patients
Patients which were randomized to undergo PCI.
Other: No intervention will take place for this retrospective and observational study.
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.
Other: No intervention will take place for this retrospective and observational study.
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.
Other: No intervention will take place for this retrospective and observational study.
No intervention will take place for this retrospective and observational study.




Primary Outcome Measures :
  1. Long-term survival status [ Time Frame: 10-year ]
    All-cause death


Secondary Outcome Measures :
  1. Cause of death [ Time Frame: 10-year ]
    Cause-specific death, separated in cardiovascular and non-cardiovascular death with specific causes for cardiovascular deaths.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria
Patients which have previously been enrolled in the SYNTAX trial (randomized and registry patients)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417050


Sponsors and Collaborators
Erasmus Medical Center
Investigators
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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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stuart Head, MD, PhD, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03417050     History of Changes
Other Study ID Numbers: MEC-2016-716
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stuart Head, Erasmus Medical Center:
coronary artery bypass grafting
percutaneous coronary intervention
drug eluting stent
survival status
long-term follow-up
complex coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases