A Study to Evaluate Safety and Efficacy of the ExcelTM Sirolimus Eluting Stent With a Biodegradable Polymer Versus Sirolimus Eluting Stent With Non-Biodegradable Polymer in the Treatment of Patients With de Novo Coronary Artery Lesions

NCT00825773 | Unknown Phase 4 DMC

• 2 other identifiers: H-09-01-19ZSH-20090119
• Study Type: interventional
• Target: 1,944
• Locations: 1 country
• Sites: 1

Brief Summary

E.V.O.L.U.T.I.O.N.: A Randomized Study to Evaluate Safety and Efficacy of the Excel Sirolimus Eluting Stent with a Biodegradable Polymer Versus Sirolimus Eluting Stent with a Non-Biodegradable Polymer in the Treatment of Patients with de novo Coronary Artery Lesions.

Conditions

Ischemia; Cardiac Death; Myocardial Infarction

Keywords

TVF; TLF; MACE; Ischemia-driven Target Vessel Failure (TVF) at 12 months.; Ischemia-driven Target Lesion Failure (TLF) at 12 months defined as a; composite of cardiac death that can not be clearly attributed to a vessel; other than the target vessel, target vessel MI (Q and Non-Q wave) and; ischemia-driven TLR.; Rates of stent thrombosis, defined (per ARC definition) as definite or probable; and categorized as early, late or very late.; Major Adverse Cardiac Events (MACE) defined as cardiac death, target; vessel MI (Q and Non-Q wave), or target lesion revascularization (TLR) at 30; days, 6 months, 12 months and 2 to 5 years annually.

Outcome Measures

Primary Outcomes (1)

• Ischemia-driven Target Vessel Failure which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target vessel revascularization (TVR) at 12 months.

  12 months

Secondary Outcomes (3)

• Rates of stent thrombosis

  5 years

• Rates for each component of the TLF composite endpoint at 12 months post-procedure

  5 years

• Major Adverse Cardiac Events (MACE) at 30 days, 6 months, 12 months and 2 to 5 years annually

  5 years

Study Arms (2)

Excel

ACTIVE COMPARATOR

Patients will be randomly assigned (2:1) to one of two treatment arms (the Excel DES or the Cypher DES). Randomization will be stratified by study site and number of vessels intended to be treated by the site investigator. Randomization will be accomplished through use of envelope randomization at the sites using the pre-assigned envelope randomization system. The study patient is considered enrolled upon randomization.

Device: Percutaneous Transluminal Coronary Angioplasty

Cypher

SHAM COMPARATOR

Patients will be randomly assigned (2:1) to one of two treatment arms (the Excel DES or the Cypher DES). Randomization will be stratified by study site and number of vessels intended to be treated by the site investigator. Randomization will be accomplished through use of envelope randomization at the sites using the pre-assigned envelope randomization system. The study patient is considered enrolled upon randomization.

Device: Percutaneous Transluminal Coronary Angioplasty

Interventions

Percutaneous Transluminal Coronary Angioplasty DEVICE

Patients will be randomly assigned (2:1) to one of two treatment arms (the Excel DES or the Cypher DES). Randomization will be stratified by study site and number of vessels intended to be treated by the site investigator. Randomization will be accomplished through use of envelope randomization at the sites using the pre-assigned envelope randomization system. The study patient is considered enrolled upon randomization.

Also known as: EVOLUTION, EXCEL vs CYPHER

Cypher; Excel

Eligibility Criteria

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

You may qualify if:

• Patient \> 18 years of age.
• Diagnosis of stable angina, unstable angina or silent ischemia (evidence of myocardial ischemia).
• Positive functional study or reversible change in the electrocardiogram (ECG) consistent with ischemia.
• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Patient must agree to undergo all required follow-up exam- inations.
• Presence of one or more de novo coronary artery stenosis \> 50% in native coronary arteries that corresponds with the evidence of ischemia. NOTE: In the presence of multiple de novo coronary lesions a maximum of four (4) planned Excel or Cypher stents may be used.
• The target lesion(s) must be \< 24mm in length and the reference diameter is \> 2.5 mm and \< 3.75 mm (visual estimate).

You may not qualify if:

• Patient is pregnant or breast feeding.
• Patient is allergic or has a contraindication to aspirin, clopidogrel and ticlopidine, heparin and bivalirudin, stainless steel, PLA, contrast media (that can not be adequately pre- medicated), and sirolimus (or its analogues).
• Patient has evidence of an Acute Myocardial Infarction evidenced by elevation of CK/CK-MB or Troponin per clinical site standards, within 72 hours of the index procedure.
• Patient is unable to provide informed consent.
• Patient is participating in another device or drug study that has not reached the primary endpoint of the study.
• Patient is considered for a DES other than the Excel or the Cypher stents.
• Patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, comply with follow- up requirements and impact the scientific integrity of the study.
• Patient has undergone previous stenting anywhere within the target vessel(s) within the previous 12 months, or will require stenting within the target vessel(s) within 12 months after the study procedure, or has received coronary brachytherapy at anytime.
• Heavily calcified target lesion(s) which cannot be successfully pre-dilated.
• Target lesion(s) involves a side branch \>2.5 mm in diameter, or \< 2.5 mm in diameter requiring treatment.
• Patient has an unprotected Left Main Coronary Lesion with a diameter of \>= 50%.
• Anticipated use of rotoblator or cutting balloon on target lesion(s).

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

Study Sites (1)

JW Medical Systems

Beijing, 100037, China

RECRUITING

Related Publications (1)

• Salam AM, Al Suwaidi J, Holmes DR Jr. Drug-eluting coronary stents. Curr Probl Cardiol. 2006 Jan;31(1):8-119. doi: 10.1016/j.cpcardiol.2005.09.002.

  PMID: 16389102 BACKGROUND

MeSH Terms

Conditions

Ischemia; Death; Myocardial Infarction; Cardiovascular Diseases; Erythema Multiforme

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Necrosis; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Intervention Hierarchy (Ancestors)

Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Central Study Contacts

Lei Ge, Prof

CONTACT

+8613816112695; ge.lei@zs-hospital.sh.cn

Yongzhi Yan, Post-gradulate

CONTACT

+8613910074132; yongzhi.yan@jwmsgrp.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: October 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2014
• Last Updated: January 26, 2009

Record last verified: 2009-01

Locations

CN (1)