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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Cardio Research Enschede BV.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT01066650
First received: February 9, 2010
Last updated: June 4, 2012
Last verified: June 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):

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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Unstable
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on October 01, 2014