Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent (Evolve)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01135225
First received: May 31, 2010
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.


Condition Intervention Phase
Coronary Artery Disease
Device: PROMUS(TM) Element (TM) Stent System
Device: Evolution Stent System
Phase 1

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: EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure:

    • Cardiac Death related to target vessel
    • Target Vessel Myocardial Infarction (TV-MI)
    • Target Lesion Revascularization (TLR)

  • In-stent late loss at 6 month post-procedure [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
    In-stent late loss at 6 months post-procedure measured by Quantitative Coronary Angiography (QCA)


Secondary Outcome Measures:
  • Target lesion revascularization (TLR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: No ]
  • Target vessel revascularization (TVR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: No ]
  • Target lesion failure (TLF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: No ]
  • Target vessel failure (TVF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: No ]
  • Cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: Yes ]
  • Non-cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: Yes ]
  • MI rate (TV and overall)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis rate (by Academic Research Consortium [ARC] definition)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years [ Time Frame: 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 291
Study Start Date: July 2010
Estimated Study Completion Date: May 2016
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PROMUS(TM) Element(TM) Coronary Stent
PROMUS(TM) Element(TM) Everolimus-Eluting Coronary Stent System
Device: PROMUS(TM) Element (TM) Stent System
The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.
Experimental: Evolution Coronary Stent A
Evolution Everolimus-Eluting Monorail Coronary Stent System
Device: Evolution Stent System
The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).
Experimental: Evolution Coronary Stent B
Evolution Everolimus-Eluting Monorail Coronary Stent System
Device: Evolution Stent System
The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).

  Eligibility

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

Inclusion Criteria:

  • Patient must be at least 18 years of age
  • Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
  • Patient is eligible for percutaneous coronary intervention (PCI)
  • Patient has symptomatic coronary artery disease or documented silent ischemia
  • Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
  • Patient has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment
  • Patient is willing to comply with all protocol-required follow-up evaluations

Exclusion Criteria:

  • Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
  • Patient with unstable angina or recent MI (within 72 hours) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:

    1. If CK MB >2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
    2. If CK Total >2× ULN, either CK-MB or troponin must be drawn and the patient is excluded if either CK-MB or troponin is abnormal.
    3. If neither CK Total or CK MB is drawn but troponin is, the patient is excluded if:

      • Troponin >1× ULN and the patient has at least one of the following:
      • Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB])
      • Development of pathological Q waves in the ECG; or;
      • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Patients with stable angina must have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these patients do not need to be available prior to the index procedure and there are no exclusion criteria based on these studies.
  • Patient has received an organ transplant or is on a waiting list for an organ transplant
  • Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
  • Patient is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded ) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
  • Patient is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome
  • Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
  • Patient has a white blood cell (WBC) count <3,000 cells/mm3
  • Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
  • Patient is on dialysis or has known renal insufficiency (e.g. serum creatinine level >2.0 mg/dL)
  • Patient has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy, or will refuse transfusions
  • Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
  • Target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
  • Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to the index procedure
  • Non-target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure Note: 1 lesion in a non-target vessel may be treated during the index procedure prior to the treatment of the target (study) lesion. The treatment of lesion(s) in non-target vessels more than 24 hours prior to the procedure does not preclude the treatment of an additional non-target lesion during the index procedure. For example, a patient could have an RCA lesion treated 7 days prior to the index procedure and then have a non-target lesion in the LCx and a target lesion in the LAD treated during the index procedure.
  • Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
  • Planned PCI or CABG after the index procedure
  • Patient previously treated at any time with coronary intravascular brachytherapy
  • Patient has a known allergy to the trial stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
  • Patient has one of the following.

    • Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
    • Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.
    • Planned procedure that may cause non-compliance with the protocol or confound data interpretation
  • Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  • Patient intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  • Patient with known intention to procreate within 12 months after the index procedure. (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
  • Patient is a woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential.)
  • Patient has more than 1 target lesion and 1 non-target lesion that will be treated during the index procedure

Angiographic Inclusion criteria (Visual Estimate):

  • Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤3.5 mm.
  • Target lesion length must be ≤ 28 mm (by visual estimate)
  • Target lesion must have visually estimated stenosis ≥50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.
  • Target lesion must be successfully pre-dilatated.

Angiographic Exclusion criteria (visual estimate):

  • Target lesion meets any of the following criteria.

    • Left main location
    • Located within 5 mm of the origin of the left anterior descending (LAD), left circumflex (LCX) or RCA by visual estimate
    • Located within a saphenous vein graft or an arterial graft
    • Will be accessed via a saphenous vein graft or arterial graft
    • Involves a side branch ≥2.0 mm in diameter by visual estimate
    • Involves a side branch <2.0 mm in diameter by visual estimate which requires treatment
    • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
    • Excessive tortuosity proximal to or within the lesion
    • Excessive angulation proximal to or within the lesion
    • Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
    • Restenotic from previous intervention
    • Thrombus, or possible thrombus, present in the target vessel
    • Target lesion cannot be covered by a single study stent
  • Patient has unprotected left main coronary artery disease (>50% diameter stenosis)
  • Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
  • Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure may be required
  • Non-target lesion to be treated during the index procedure meets any of the following criteria.

    • Located within the target vessel
    • Located within a bypass graft (venous or arterial)
    • Left main location
    • Chronic total occlusion
    • Involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
    • Requires additional unplanned stents
    • Treatment not deemed a clinical angiographic success
    • Treatment not completed prior to treatment of target lesion
  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: NCT01135225

Locations
Australia
The Prince Charles Hospital
Chermside, Australia, QLD 4032
Monash Medical Centre
Clayton, Australia, VIC 3168
St. Vincent's Hospital (Melbourne)
Fitzroy, Australia, VIC 3065
Fremantle Hospital
Fremantle, Australia, 6160
Belgium
Academisch Ziekenhuis Middelheim
Antwerpen, Belgium, 2020
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
UZ Gasthuisberg
Leuven, Belgium, 3000
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, Belgium, 4000
Denmark
Rigshospitalet Thoraxkirurgisk Klinik RT
Copenhagen, Denmark, 2100
Skejby Sygehus
Århus, Denmark, 8200
France
Polyclinique Les Fleurs
Ollioules, France, 83190
Hôpital Cochin
Paris, France, 75014
Hôpital Rangueil
Toulouse, France, 31059
Clinique Pasteur
Toulouse, France, 31087
New Zealand
Dunedin Hospital
Dunedin, New Zealand, 9016
Middlemore Hospital
Otahuhu, New Zealand, 1640
North Shore Hospital
Takapuna, New Zealand, 0622
Poland
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy
Bydgoszcz, Poland, 85-094
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Virgen de la Arrixaca
El Palmar, Spain, 30120
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Clinico San Carlos
Madrid, Spain, 28040
Sweden
Falu lasarett
Falun, Sweden, 79182
Uppsala Akademiska Hospital
Uppsala, Sweden, 756 52
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom, BT 12 6BA
Papworth Hospital
Cambridge, United Kingdom, CB3 8RE
Golden Jubilee National Hospital
Clydebank, United Kingdom, G81 4HX
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom, L14 3PE
John Radcliffe Hospital
Oxford, United Kingdom, 0X3 9DU
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Ian Meredith, Prof Monash Medical Centre
Principal Investigator: Stefan Verheye, Dr AZ Middelheim
  More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01135225     History of Changes
Other Study ID Numbers: S2060
Study First Received: May 31, 2010
Last Updated: February 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Boston Scientific Corporation:
Drug-eluting stent
Percutaneous coronary intervention
Stent implantation
Evolution Stent System
Biodegradable polymer coating
Feasibility study

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014