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

NCT01135225 | Completed DMC

• 1 other identifier: S2060
• Study Type: interventional
• Target: 291
• Locations: 9 countries
• Sites: 29

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Drug-eluting stent; Percutaneous coronary intervention; Stent implantation; Evolution Stent System; Biodegradable polymer coating; Feasibility study

Outcome Measures

Primary Outcomes (2)

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

  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)

  30 days

• In-stent late loss at 6 month post-procedure

  In-stent late loss at 6 months post-procedure measured by Quantitative Coronary Angiography (QCA)

  6 months post-procedure

Secondary Outcomes (8)

• Target lesion revascularization (TLR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Target vessel revascularization (TVR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Target lesion failure (TLF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Target vessel failure (TVF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

  30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

Study Arms (3)

PROMUS(TM) Element(TM) Coronary Stent

ACTIVE COMPARATOR

PROMUS(TM) Element(TM) Everolimus-Eluting Coronary Stent System

Device: PROMUS(TM) Element (TM) Stent System

Evolution Coronary Stent A

EXPERIMENTAL

Evolution Everolimus-Eluting Monorail Coronary Stent System

Device: Evolution Stent System

Evolution Coronary Stent B

EXPERIMENTAL

Evolution Everolimus-Eluting Monorail Coronary Stent System

Device: Evolution Stent System

Interventions

PROMUS(TM) Element (TM) Stent System DEVICE

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.

PROMUS(TM) Element(TM) Coronary Stent

Evolution Stent System DEVICE

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).

Evolution Coronary Stent A; Evolution Coronary Stent B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• If CK MB \>2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
• 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.
• 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;
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (29)

The Prince Charles Hospital

Chermside, QLD 4032, Australia

Location

Monash Medical Centre

Clayton, VIC 3168, Australia

Location

St. Vincent's Hospital (Melbourne)

Fitzroy, VIC 3065, Australia

Location

Fremantle Hospital

Fremantle, 6160, Australia

Location

Academisch Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman Liège

Liège, 4000, Belgium

Location

Skejby Sygehus

Aarhus, 8200, Denmark

Location

Rigshospitalet Thoraxkirurgisk Klinik RT

Copenhagen, 2100, Denmark

Location

Polyclinique Les Fleurs

Ollioules, 83190, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31087, France

Location

Dunedin Hospital

Dunedin, 9016, New Zealand

Location

Middlemore Hospital

Otahuhu, 1640, New Zealand

Location

North Shore Hospital

Takapuna, 0622, New Zealand

Location

Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

Bydgoszcz, 85-094, Poland

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, 30120, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Falu lasarett

Falun, 79182, Sweden

Location

Uppsala Akademiska Hospital

Uppsala, 756 52, Sweden

Location

Royal Victoria Hospital

Belfast, BT 12 6BA, United Kingdom

Location

Papworth Hospital

Cambridge, CB3 8RE, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, G81 4HX, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

John Radcliffe Hospital

Oxford, 0X3 9DU, United Kingdom

Location

Related Publications (3)

• Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Valdes Chavarri M, West NE, Kelbaek H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjogren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 Jul;9(3):308-15. doi: 10.4244/EIJV9I3A52.

  PMID: 23872647 DERIVED

• Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Chavarri MV, West NE, Kelbaek H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjogren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 May 22:20130416-02. Online ahead of print.

  PMID: 23688934 DERIVED

• Meredith IT, Verheye S, Dubois CL, Dens J, Fajadet J, Carrie D, Walsh S, Oldroyd KG, Varenne O, El-Jack S, Moreno R, Joshi AA, Allocco DJ, Dawkins KD. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol. 2012 Apr 10;59(15):1362-70. doi: 10.1016/j.jacc.2011.12.016. Epub 2012 Feb 15.

  PMID: 22341736 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ian Meredith, Prof

  Monash Medical Centre

  PRINCIPAL INVESTIGATOR

• Stefan Verheye, Dr

  AZ Middelheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: June 2, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: April 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

PL (1); ES (4); BE (4); AU (4); SE (2); FR (4); DK (2); NZ (3); GB (5)