Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

Status Completed

Clinical Trial Summary

A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Intervention

Clinical Trial Description

Objectives: The purpose of this study is to compare the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) with a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) in a non-inferiority trial.

Design: Prospective, multi-center, randomized, non-inferiority trial to be conducted at 3 Swiss interventional cardiology centers. Patients will be randomized in a single-blind fashion (1:1 randomization) to either the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) or the Zotarolimus-Eluting Stent (EndeavorTm, Medtronic).

Study Population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction, who qualify for percutaneous coronary interventions

Antiplatelet Therapy: Aspirin 100 mg qd indefinitely; Clopidogrel 75 mg qd for 3 months

Enrollment: A total of 300 patients will be enrolled

All patients will undergo repeat angiography at 6-8 months.

All patients will be followed for up to 5 years. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00492908
Study type	Interventional
Source	University of Bern
Contact
Status	Completed
Phase	Phase 4
Start date	June 2007
Completion date	August 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Completed	`NCT05088291` - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Completed	`NCT04584645` - A Digital Flu Intervention for People With Cardiovascular Conditions	N/A
Not yet recruiting	`NCT04995159` - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System	N/A
Recruiting	`NCT02967718` - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome	N/A
Completed	`NCT02888652` - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Completed	`NCT02163044` - The Hellenic Postprandial Lipemia Study (HPLS)
Terminated	`NCT02045134` - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery	N/A
Active, not recruiting	`NCT02244853` - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease	N/A
Completed	`NCT01920009` - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines	N/A
Completed	`NCT02440893` - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Completed	`NCT01826552` - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent	Phase 4
Completed	`NCT02753829` - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease	N/A
Terminated	`NCT01906957` - Cognition and Exercise Training	N/A
Recruiting	`NCT01689688` - Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography	N/A
Completed	`NCT01779401` - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients	N/A
Recruiting	`NCT01456364` - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing	Phase 4
Recruiting	`NCT01462799` - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care	N/A
Completed	`NCT01428947` - Does Coronary Angiography Cause Cognitive Dysfunction?	N/A