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

Primary Purpose

Coronary Artery Disease, Autosomal Dominant, 1

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Endeavor® Zotarolimus Eluting Coronary Stent System
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease, Autosomal Dominant, 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Massachusetts Memorial Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endeavor® Zotarolimus Eluting Coronary Stent

Arm Description

Endeavor® Zotarolimus Eluting Coronary Stent System

Outcomes

Primary Outcome Measures

To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation
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.
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.

Full Information

First Posted
February 18, 2009
Last Updated
April 13, 2015
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT00846846
Brief Title
PROTECT Continued Access Post Marketing Surveillance Trial
Acronym
PROTECT-CA
Official Title
Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial: PROTECT Continued Access Post Marketing Surveillance Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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").
Detailed Description
This was a prospective, multicenter, non-randomized, single-arm, open-label post market surveillance study designed to expand safety information in patients treated with the Endeavor® Zotarolimus Eluting Coronary Stent System. Since their introduction, Drug Eluting Stents (DES) have markedly decreased stent restenosis and the clinical need for repeat revascularization frequently observed with bare metal stents (BMS)1-10. However, the widespread use of DES has raised concerns regarding the occurrence of late stent thrombosis (> 30 days after stent implantation)12-14. Although the incidence might seem low (0.2-0.7%)13,15-18 the high mortality and morbidity associated with stent thrombosis, and the soaring number of stents implanted annually, make it a significant medical problem. The purpose of this trial was to investigate the long-term clinical safety and efficacy of the Endeavor drug eluting stent in a large and higher risk patient population, which more closely reflects clinical practice today. Both unstable and stable patients with single or multivessel disease and complex lesions were eligible for enrollment. The selected primary endpoint was stent thrombosis, defined as definite and probable stent thrombosis according to the ARC definition, at 3 years. The main secondary endpoints were the composite of death or cardiac death combined with large or all non-fatal myocardial infarction, which are the typical clinical manifestations of stent thrombosis. These events are adjudicated by a clinical events committee. 1.2 Study Endpoints 1.2.1 Primary Endpoint: The overall stent thrombosis rate defined as definite and probable stent thrombosis according to the ARC definition at 3 years 1.2.2 Secondary Endpoints: Main Secondary Endpoints include: Composite endpoint of total death and number of patients with all non-fatal myocardial infarction at 3 years Composite endpoint of cardiac death and number of patients with all non-fatal myocardial infarction at 3 years Composite endpoint of total death and number of patients with large non-fatal myocardial infarction at 3 years Composite endpoint of cardiac death and number of patients with large non-fatal myocardial infarction at 3 years Additional secondary endpoints include: Total Death and subcategories of Death Large and all Myocardial Infarction (MI) Stent thrombosis defined as definite, probable and possible Composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) * Major Adverse Cardiac and Cerebral Events (MACCE) Stroke (hemorrhagic in nature while on clopidogrel) Bleeding complications in general Target lesion revascularization (TLR) Target vessel revascularization (TVR) Non target vessel revascularization (non TVR) Procedural success Device success Lesion success Endpoints will be calculated at the follow-up time points and for the mean follow-up period. The composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) constructed from a patient population according to the Delphi method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Autosomal Dominant, 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1018 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endeavor® Zotarolimus Eluting Coronary Stent
Arm Type
Experimental
Arm Description
Endeavor® Zotarolimus Eluting Coronary Stent System
Intervention Type
Device
Intervention Name(s)
Endeavor® Zotarolimus Eluting Coronary Stent System
Intervention Description
Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation
Primary Outcome Measure Information:
Title
To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation
Description
The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is > 18 years of age (or minimum age as required by local regulations). 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". 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. 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: 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 brachytherapy. 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. 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. 16 Transplant patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Bousquette
Organizational Affiliation
Medtronic Cardiovascular
Official's Role
Study Director
Facility Information:
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

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PROTECT Continued Access Post Marketing Surveillance Trial

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