Ischemic Heart Disease Clinical Trial
Official title:
PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
| Active, not recruiting |
NCT04562805 -
Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)
|
N/A | |
| Recruiting |
NCT05292079 -
CAPTURER PMCF Study ( rEPIC04D )
|
||
| Recruiting |
NCT05292092 -
Essential Pro PMCF Study ( rEPIC04E )
|
||
| Recruiting |
NCT05292014 -
ANGIOLITE PMCF Study ( rEPIC04F )
|
||
| Recruiting |
NCT05292118 -
Navitian PMCF Study ( rEPIC04C )
|
||
| Completed |
NCT05292105 -
NC Xperience PMCF Study( rEPIC04B)
|
||
| Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
| Not yet recruiting |
NCT04153383 -
Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
|
||
| Recruiting |
NCT02729064 -
Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose
|
Phase 1 | |
| Recruiting |
NCT02982434 -
The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
|
Phase 2 | |
| Completed |
NCT02468401 -
Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
|
N/A | |
| Completed |
NCT02759406 -
Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study
|
N/A | |
| Recruiting |
NCT01681381 -
Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization
|
N/A | |
| Completed |
NCT01604213 -
Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease
|
Phase 4 | |
| Completed |
NCT01699802 -
Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)
|
N/A | |
| Completed |
NCT01724567 -
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training
|
N/A | |
| Completed |
NCT01334268 -
RESOLUTE China RCT
|
N/A | |
| Completed |
NCT02159235 -
Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)
|
N/A |