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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 (EVOLUTION)

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ClinicalTrials.gov Identifier: NCT00825773
Recruitment Status : Unknown
Verified January 2009 by JW Medical Systems Ltd.
Recruitment status was:  Recruiting
First Posted : January 21, 2009
Last Update Posted : January 26, 2009
Sponsor:
Information provided by:
JW Medical Systems Ltd

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.

Condition or disease Intervention/treatment Phase
Ischemia Cardiac Death Myocardial Infarction Device: Percutaneous Transluminal Coronary Angioplasty Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1944 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized 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
Study Start Date : October 2008
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2014


Arm Intervention/treatment
Active Comparator: 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.
Device: 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.
Other Names:
  • EVOLUTION
  • EXCEL vs CYPHER

Sham Comparator: 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.
Device: 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.
Other Names:
  • EVOLUTION
  • EXCEL vs CYPHER




Primary Outcome Measures :
  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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Rates of stent thrombosis [ Time Frame: 5 years ]
  2. Rates for each component of the TLF composite endpoint at 12 months post-procedure [ Time Frame: 5 years ]
  3. Major Adverse Cardiac Events (MACE) at 30 days, 6 months, 12 months and 2 to 5 years annually [ Time Frame: 5 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Angiographic Inclusion Criteria:

  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.

Angiographic Exclusion Criteria:

  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825773


Contacts
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Contact: Lei Ge, Prof +8613816112695 ge.lei@zs-hospital.sh.cn
Contact: Yongzhi Yan, Post-gradulate +8613910074132 yongzhi.yan@jwmsgrp.com

Locations
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China
JW Medical Systems Recruiting
Beijing, China, 100037
Contact: Yong zhi Yan, Post-graduate    +8613910074132    yongzhi.yan@jwmsgrp.com   
Contact: Lei Ge, Prof    +8613816112695    ge.lei@zs-hospital.sh.cn   
Principal Investigator: Junbo Ge, Prof         
Sponsors and Collaborators
JW Medical Systems Ltd

Publications:
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Responsible Party: Yongzhi Yan, JW Medical Systems Ltd
ClinicalTrials.gov Identifier: NCT00825773     History of Changes
Other Study ID Numbers: H-09-01-19
ZSH-20090119
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009
Keywords provided by JW Medical Systems Ltd:
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.
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Death
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Chlorhexidine
Chlorhexidine gluconate
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents