PROTECT Continued Access Post Marketing Surveillance Trial (PROTECT-CA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00846846
First received: February 18, 2009
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA").


Condition Intervention Phase
Coronary Artery Disease, Autosomal Dominant, 1
Device: Endeavor® Zotarolimus Eluting Coronary Stent System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial: PROTECT Continued Access Post Marketing Surveillance Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.


Secondary Outcome Measures:
  • Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Total death and and number of patients with all non-fatal myocardial infarction. Cardiac death and number of patients with all non-fatal myocardial infarction. Total death and number of patients with large non-fatal myocardial infarction. Cardiac death and number of patients with large non-fatal myocardial infarction.


Enrollment: 1018
Study Start Date: January 2009
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Endeavor® Zotarolimus Eluting Coronary Stent System
Endeavor® Zotarolimus Eluting Coronary Stent System
Device: Endeavor® Zotarolimus Eluting Coronary Stent System
Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is > 18 years of age (or minimum age as required by local regulations).
  2. The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
  3. 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.
  4. 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. Please check the 'Instructions for Use' that comes with the product. Please be aware that the 'Instructions for Use' may be subject to change during the course of the study.

5 The patient is willing and able to cooperate with study procedures and required follow up visits.

Exclusion Criteria:

  1. Women with known pregnancy or who are lactating.
  2. Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
  3. Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
  4. Previous brachytherapy.
  5. Previous implantation of a drug eluting stent.
  6. Previous implantation of a bare metal stent in the preceding year.
  7. Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.
  8. Current medical condition with a life expectancy of less than 3 years.
  9. Manifest acute severe heart failure (Killip class III-IV).
  10. 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.
  11. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
  12. Patients on warfarin or similar anti-coagulant therapy.
  13. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use.
  14. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
  15. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.

16 Transplant patients.

  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: NCT00846846

Locations
United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
Medtronic Vascular
Investigators
Study Director: Lisa Bousquette Medtronic Cardiovascular
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00846846     History of Changes
Other Study ID Numbers: Version 1.0, 29 October 2008
Study First Received: February 18, 2009
Results First Received: May 30, 2014
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014