Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Biotronik AG
University of Bern
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01443104
First received: September 21, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia and to reduce the rate of restenosis and target-lesion revascularization as compared to bare-metal stents. Drug-eluting stents consist of a metallic platform and a therapeutic substance that is usually released from a polymer matrix. A previous study utilizing a bioresorbable polymer has demonstrated a favorable safety and efficacy profile in a large-scale clinical trial as compared to a first-generation druf-eluting stent (LEADERS trial).

The objective of the study is to compare the safety and efficacy of a sirolimus-eluting stent with a biodegradable polymer with an everolimus-eluting stent with a durable polymer in a prospective multicenter randomized controlled non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.


Condition Intervention Phase
Coronary Artery Disease
Angina Pectoris
Myocardial Infarction
Device: Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)
Device: Everolimus-eluting stent with a durable polymer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of a Sirolimus-eluting Stent With Biodegradable Polymer Versus an Everolimus-eluting Stent With a Durable Polymer for Percutaneous Coronary Revascularization

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Target lesion failure (TLF), defined as the composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) and emergent coronary artery bypass grafting (CABG) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with target lesion revascularization (TLR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of patients with target lesion revascularization (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of patients with target lesion revascularization (TLR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of patients with target lesion revascularization (TLR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Clinically indicated and not clinically indicated target vessel revascularization (TVR) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinically indicated and not clinically indicated target vessel revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Clinically indicated and not clinically indicated target vessel revascularization (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinically indicated and not clinically indicated target vessel revascularization (TVR) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • TLF composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • TLF composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • TLF composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Definite stent thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Definite stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Definite stent thrombosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Definite stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Definite stent thrombosis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q-wave and NQWMI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q-wave and NQWMI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q-wave and NQWMI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q-wave and NQWMI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (Q-wave and NQWMI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2100
Study Start Date: February 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Orsiro Stent
Sirolimus-eluting Stent with a Biodegradable Polymer
Device: Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)
Percutaneous coronary intervention with implantation of a sirolimus-eluting stent with a bioresorbable polymer for coronary artery disease
Active Comparator: Xience Prime Stent
Everolimus-eluting Stent with a Durable Polymer
Device: Everolimus-eluting stent with a durable polymer
Percutaneous coronary intervention with implantation of an everolimus-eluting stent with a durable polymer for coronary artery disease

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Age ≥18 years
  • Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS
  • Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents
  • No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria

  • Pregnancy
  • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus or contrast material
  • Inability to provide informed consent
  • Currently participating in another trial before reaching first endpoint
  • Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
  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: NCT01443104

Locations
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5000
Universitätsklinik Basel
Basel, Switzerland, 4031
Department of Cardiology, Bern University Hospital
Bern, Switzerland, 3010
HFR Freiburg
Freiburg, Switzerland, 1708
Hôpitaux Universitaires de Genève
Genève, Switzerland, 1211
Service de cardiologie CHUV
Lausanne, Switzerland, 1010
Luzerner Kantonsspital
Luzern, Switzerland, 6004
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Stadtspital Triemli
Zürich, Switzerland, 8055
Sponsors and Collaborators
University Hospital Inselspital, Berne
Biotronik AG
University of Bern
Investigators
Principal Investigator: Stephan Windecker Department of Cardiology, Bern University Hospital, Switzerland
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Stephan Windecker, Department of Cardiology, Bern University Hospital
ClinicalTrials.gov Identifier: NCT01443104     History of Changes
Other Study ID Numbers: 065/11
Study First Received: September 21, 2011
Last Updated: June 23, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
coronary artery disease
drug-eluting stents
polymers

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014