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: October 30, 2013
Last verified: October 2013

February 18, 2009
October 30, 2013
January 2009
March 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00846846 on ClinicalTrials.gov Archive Site
  • Composite endpoint of total death and number of patients with all non-fatal myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite endpoint of cardiac death and number of patients with all non-fatal myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite endpoint of total death and number of patients with large non-fatal myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Composite endpoint of cardiac death and number of patients with large non-fatal myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
PROTECT Continued Access Post Marketing Surveillance Trial
Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial: PROTECT Continued Access Post Marketing Surveillance Trial

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").

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease, Autosomal Dominant, 1
Device: Endeavor® Zotarolimus Eluting Coronary Stent System
Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation
Endeavor® Zotarolimus Eluting Coronary Stent System
Endeavor® Zotarolimus Eluting Coronary Stent System
Intervention: Device: Endeavor® Zotarolimus Eluting Coronary Stent System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
March 2015
March 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00846846
Version 1.0, 29 October 2008
No
Medtronic Vascular
Medtronic Vascular
Not Provided
Study Director: Lisa Bousquette Medtronic Cardiovascular
Medtronic Vascular
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP