Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

NCT00476957 | Completed Phase 4 Results DMC

• 1 other identifier: Version 1.0 - 12 April 2007
• Study Type: interventional
• Target: 8,709
• Locations: 1 country
• Sites: 1

Brief Summary

The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions. Study Stents: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation Secondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation. To assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.

Conditions

Ischemic Heart Disease

Keywords

Drug Eluting Stents; Interventional Cardiology

Outcome Measures

Primary Outcomes (1)

• To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation

  Definite or probable stent thrombosis rate.

  3 years

Secondary Outcomes (1)

• Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions

  3 years

Study Arms (2)

1

ACTIVE COMPARATOR

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

Device: Stent

2

ACTIVE COMPARATOR

Cordis Cypher® Sirolimus-eluting Coronary Stent

Device: Stent

Interventions

Stent DEVICE

Stent implantation

Also known as: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System

1

Eligibility Criteria

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

You may qualify if:

• Patient is \> 18 years of age (or minimum age as required by local regulations).
• The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
• All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System or Cypher® Sirolimus-eluting Coronary Stent\*.
• Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System and Cypher® Sirolimus-eluting Coronary Stent. Patients should qualify for both systems before randomization\*.
• The patient is willing and able to cooperate with study procedures and required follow up visits.

You may not qualify if:

• Women with known pregnancy or who are lactating.
• Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
• Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
• Previous brachy-therapy.
• Previous implantation of a drug eluting stent.
• Previous implantation of a bare metal stent in the preceding year.
• Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.
• Current medical condition with a life expectancy of less than 3 years.
• Manifest acute severe heart failure (Killip class III-IV).
• The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.
• Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
• Patients on warfarin or similar anti-coagulant therapy.
• Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
• Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.

Sponsors & Collaborators

• Medtronic Vascular: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (1)

196 enrolling sites Worldwide

Maastricht, Netherlands

Location

Related Publications (6)

• Camenzind E, Wijns W, Mauri L, Boersma E, Parikh K, Kurowski V, Gao R, Bode C, Greenwood JP, Gershlick A, O'Neill W, Serruys PW, Jorissen B, Steg PG; PROTECT Steering Committee and Investigators. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am Heart J. 2009 Dec;158(6):902-909.e5. doi: 10.1016/j.ahj.2009.10.002.

  PMID: 19958855 BACKGROUND

• Camenzind E, Wijns W, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Boersma E, Vranckx P, McFadden E, Serruys PW, O'Neil WW, Jorissen B, Van Leeuwen F, Steg PG; PROTECT Steering Committee and Investigators. Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial. Lancet. 2012 Oct 20;380(9851):1396-405. doi: 10.1016/S0140-6736(12)61336-1. Epub 2012 Aug 27.

  PMID: 22951082 RESULT

• Roguin A, Camenzind E, Kerner A, Beyar R, Boersma E, Mauri L, Steg PG, Wijns W. Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial. JACC Cardiovasc Interv. 2017 Mar 27;10(6):548-556. doi: 10.1016/j.jcin.2016.12.028.

  PMID: 28335893 DERIVED

• Secemsky EA, Matteau A, Yeh RW, Steg PG, Camenzind E, Wijns W, McFadden E, Mauri L; PROTECT Trial Investigators. Comparison of Short- and Long-Term Cardiac Mortality in Early Versus Late Stent Thrombosis (from Pooled PROTECT Trials). Am J Cardiol. 2015 Jun 15;115(12):1678-84. doi: 10.1016/j.amjcard.2015.03.010. Epub 2015 Mar 23.

  PMID: 25910523 DERIVED

• Wijns W, Steg PG, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Lipsic E, Alamgir F, Rademaker-Havinga T, Boersma E, Radke P, van Leeuwen F, Camenzind E; PROTECT Steering Committee and Investigators. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial. Eur Heart J. 2014 Oct 21;35(40):2812-20. doi: 10.1093/eurheartj/ehu318. Epub 2014 Aug 8.

  PMID: 25106761 DERIVED

• Camenzind E, Boersma E, Wijns W, Mauri L, Rademaker-Havinga T, Ordoubadi FF, Suttorp MJ, Al Kurdi M, Steg PG; PROTECT Steering Committee and Investigators. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type. Eur Heart J. 2014 Aug 1;35(29):1932-48. doi: 10.1093/eurheartj/ehu084. Epub 2014 Mar 13.

  PMID: 24627416 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Stents

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Dr. Frank van Leeuwen, Director Clinical Research Coronary and Renal Denervation
• Organization: Medtronic Bakken Research Center

frank.van.leeuwen@medtronic.com

+31 43 3566622

Study Officials

• Edoardo Camenzind, MD

  University of Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

• Laura Mauri, MD

  Brigham and Women's Hospital, US

  PRINCIPAL INVESTIGATOR

• William O'Neill, MD

  University of Miami Miller School of Medicine, US

  PRINCIPAL INVESTIGATOR

• Prof. Patrick W. Serruys, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Prof. Philippe Gabriel Steg, MD, PhD

  Département de Cardiologie, Hôpital Bichat-Claude Bernard, Assistance Publique - Hôpitaux de Paris, France

  PRINCIPAL INVESTIGATOR

• William Wijns, MD, PhD

  O.L.V. Hospital, Aalst, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 22, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2014
• Last Updated: November 10, 2014
• Results First Posted: March 17, 2014

Record last verified: 2014-11

Locations

NL (1)