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

NCT ID: NCT00825773

Last Updated: 2009-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1944 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2014-04-30

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.

Detailed Description

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.

A prospective, randomized, controlled, parallel two-arm multi-center study, comparing the ExcelTM DES to CypherTM DES in the treatment of patients with de novo coronary artery lesions.

To evaluate the safety and efficacy of the Excel DES (biodegradable polymer) compared to the Cypher DES (non-biodegradable polymer) in the treatment of patients with de novo coronary artery lesions.

Approximately 1944 patients will be enrolled in up to 25 centers in China. Primary Endpoint: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.

Secondary Endpoint:

1. 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.

2. Rates of stent thrombosis, defined (per ARC definition) as definite or probable and categorized as early, late or very late.

3. Rates for each component of the TLF composite endpoint (cardiac death, target vessel MI, ischemia- driven TLR) at 12 months post-procedure.

4. 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.

5. Device Success defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual estimate) and a TIMI flow of 3 using the Excel/Cypher DES.

6. Procedure Success defined as achievement of a final in- stent diameter stenosis of < 30% (visual estimate) and a TIMI flow of 3 using any percutaneous method, without the occurrence of in-hospital MACE. (ALL TLR IN THIS STUDY WILL BE CLINICALLY INDICATED)

Conditions

Ischemia; Cardiac Death; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Excel

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Transluminal Coronary Angioplasty

Intervention Type: 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.

Cypher

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.

Group Type: SHAM_COMPARATOR

Percutaneous Transluminal Coronary Angioplasty

Intervention Type: 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.

Interventions

Percutaneous Transluminal Coronary Angioplasty

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.

Intervention Type: DEVICE

Other Intervention Names

EVOLUTION; EXCEL vs CYPHER

Eligibility Criteria

Inclusion Criteria

1. Patient > 18 years of age.

2. Diagnosis of stable angina, unstable angina or silent ischemia (evidence of myocardial ischemia).

3. Positive functional study or reversible change in the electrocardiogram (ECG) consistent with ischemia.

4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. Patient must agree to undergo all required follow-up exam- inations.

1. 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.

2. The target lesion(s) must be < 24mm in length and the reference diameter is > 2.5 mm and < 3.75 mm (visual estimate).

Exclusion Criteria

1. Patient is pregnant or breast feeding.

2. 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).

3. 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.

4. Patient is unable to provide informed consent.

5. Patient is participating in another device or drug study that has not reached the primary endpoint of the study.

6. Patient is considered for a DES other than the Excel or the Cypher stents.

7. 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.

1. 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.

2. Heavily calcified target lesion(s) which cannot be successfully pre-dilated.

3. Target lesion(s) involves a side branch >2.5 mm in diameter, or < 2.5 mm in diameter requiring treatment.

4. Patient has an unprotected Left Main Coronary Lesion with a diameter of >= 50%.

5. Anticipated use of rotoblator or cutting balloon on target lesion(s).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JW Medical Systems Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

JW Medical Systems Ltd

Locations

JW Medical Systems

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Ge, Prof

Role: CONTACT

ge.lei@zs-hospital.sh.cn

+8613816112695

Yongzhi Yan, Post-gradulate

Role: CONTACT

yongzhi.yan@jwmsgrp.com

+8613910074132

Facility Contacts

Yong zhi Yan, Post-graduate

Role: primary

yongzhi.yan@jwmsgrp.com

+8613910074132

Lei Ge, Prof

Role: backup

ge.lei@zs-hospital.sh.cn

+8613816112695

References

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.

Reference Type: BACKGROUND

PMID: 16389102 (View on PubMed)

Other Identifiers

ZSH-20090119

Identifier Type: -

Identifier Source: secondary_id

H-09-01-19

Identifier Type: -

Identifier Source: org_study_id