Clinical trial NCT00846846: PROTECT Continued Access Post Marketing Surveillance Trial
Official title: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial: PROTECT Continued Access Post Marketing Surveillance Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease, Autosomal Dominant, 1
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 1018
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation
timeFrame: 3 years
Secondary outcomes:
measure: Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
timeFrame: 3 years
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: Medtronic Cardiovascular
name: Lisa Bousquette
role: STUDY_DIRECTOR
References: