The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente - Full Text View

Purpose

The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well.

Condition	Intervention	Phase
Coronary Artery Disease Angina Pectoris Unstable Angina Pectoris Coronary Stenosis Coronary Restenosis	Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) Device: Xience V (Everolimus-eluting stent)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Cardio Research Enschede BV:

Primary Outcome Measures:

comparing target-vessel failure (TVF) of both stents [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

the efficacy, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two second-generation drug-eluting stents [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1380
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2012
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Endeavor Resolute	Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) Drug eluting Stent Other Name: Endeavor Resolute stent
Active Comparator: Xience V	Device: Xience V (Everolimus-eluting stent) Drug eluting stent Other Name: Xience V drug eluting stent

Detailed Description:

Primary research questions

To investigate whether the clinical outcome following the randomized implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a non-inferiority setting by comparing target-vessel failure (TVF) of both stents. We want to compare for both drug-eluting stents the combined endpoint of death, myocardial infarction or revascularization related to the target-vessel, as well as death or myocardial infarction that cannot be related to a significant flow obstruction in another vessel or to another cause. According to current literature, non-inferiority of Endeavor resolute ® and XIENCE V® is expected. But the non-inferiority of Endeavor resolute and XIENCE V® is not tested in a controlled randomized trial yet.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Indication for PCI with DES implantation based on VVC/ESC guidelines and/or clinical decision of interventional cardiologist
Age ≥ 18 years and mentally capable to give an informed consent
Signed informed consent

Exclusion Criteria:

Patients with ST-elevation myocardial infarction (STEMI) or an ST- elevation myocardial infarction equivalent requiring primary PCI or rescue PCI
Patients in whom the revascularization procedure is planned to be performed in a staged approach
Renal failure requiring haemodialysis
Patient is currently participating in an investigational drug or device study that has been not completed
In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
Life expectancy less than 1 year
Patients in whom during PCI there is no indication for DES use and/or if the operator chooses not to use a DES based on the clinical situation, the patient will be excluded.
If the choice of DES is dictated by logistic reasons e.g. the required DES dimensions is provided by one manufacturer only.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066650

Locations

Netherlands
Medisch Spectrum Twnete
Enschede, Overijssel, Netherlands, 7513ER

Sponsors and Collaborators

Cardio Research Enschede BV

Investigators

Principal Investigator:

C. von Birgelen, MD,PhD,Prof

Thorax Centrum Twente

More Information

No publications provided by Cardio Research Enschede BV

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sen H, Tandjung K, Basalus MW, Löwik MM, van Houwelingen GK, Stoel MG, Louwerenburg HW, de Man FH, Linssen GC, Nijhuis R, Nienhuis MB, Verhorst PM, van der Palen J, von Birgelen C. Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and Xience V drug-eluting stents. EuroIntervention. 2012 Oct;8(6):664-71. doi: 10.4244/EIJV8I6A104.

von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, Linssen GC, Saïd SA, Kleijne MA, Sen H, Löwik MM, van der Palen J, Verhorst PM, de Man FH. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol. 2012 Apr 10;59(15):1350-61. Epub 2012 Feb 15.

Responsible Party:	prof. C. von Birgelen, Professor Clemens von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:	NCT01066650 History of Changes
Other Study ID Numbers:	TWENTE I, MST/Twente/001
Study First Received:	February 9, 2010
Last Updated:	June 4, 2012
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Cardio Research Enschede BV:

TWENTE
randomized study
stent
coronary stent
drug-eluting stent
Zotarolimus
Everolimus
Xience V
Endeavor Resolute

head to head comparison
real world patients
target vessel failure
investigator initiated study
coronary artery disease
coronary arteries
atherosclerosis
non inferiority

Additional relevant MeSH terms:

Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis

Arterial Occlusive Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 13, 2013

The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente (TWENTE)