IschemiaPhase 4EVOLUTIONNCT00825773
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
A Phase 4 study testing Percutaneous Transluminal Coronary Angioplasty in people with Ischemia and Cardiac Death, run by JW Medical Systems Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia, Cardiac Death, Myocardial Infarction
- What is being tested?
- Percutaneous Transluminal Coronary Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,944 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Angiographic Inclusion Criteria:
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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:
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
JW Medical Systems
Beijing, 100037
Yong zhi Yan, Post-graduate, +8613910074132, yongzhi.yan@jwmsgrp.com
Lei Ge, Prof, +8613816112695, ge.lei@zs-hospital.sh.cn
About this study
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
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.
Read the 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:
- 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.
- Rates for each component of the TLF composite endpoint (cardiac death, target vessel MI, ischemia- driven TLR) at 12 months post-procedure.
- 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.
- 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.
- 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
- Being tested
- Percutaneous Transluminal Coronary Angioplasty
- 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.
- Medical subject headings
- Ischemia, Death, Myocardial Infarction, Cardiovascular Diseases, Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Transluminal Coronary AngioplastyDevice
Also called EVOLUTION, EXCEL vs 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Percutaneous Transluminal Coronary Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Rates of stent thrombosis
Measured: 5 years
Rates for each component of the TLF composite endpoint at 12 months post-procedure
Measured: 5 years
Major Adverse Cardiac Events (MACE) at 30 days, 6 months, 12 months and 2 to 5 years annually
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionApr 2010 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825773
- Sponsor's protocol ID
- H-09-01-19
- Other IDs
- ZSH-20090119
- Acronym
- EVOLUTION
- Status last verified
- Jan 2009
- First submitted
- 19 Jan 2009
- Last updated
- 26 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16389102
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00825773
- Acronym / sponsor ID
- EVOLUTION / H-09-01-19
- 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.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,944 participants (estimated)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Rates for each component of the TLF composite endpoint (cardiac death, target vessel MI, ischemia- driven TLR) at 12 months post-procedure.
- 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.
- 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.
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excel | Active comparator | Device: Percutaneous Transluminal Coronary AngioplastyPatients 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 | Sham comparator | Device: Percutaneous Transluminal Coronary AngioplastyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Transluminal Coronary AngioplastyAlso: EVOLUTION, EXCEL vs CYPHERPatients 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 | Cypher, Excel |
Primary outcome
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
3 secondary outcomes
Rates of stent thrombosis
Time frame: 5 years
Rates for each component of the TLF composite endpoint at 12 months post-procedure
Time frame: 5 years
Major Adverse Cardiac Events (MACE) at 30 days, 6 months, 12 months and 2 to 5 years annually
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2009.
- Background: PubMed 16389102Salam 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.
Related trials for Ischemia
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous Transluminal Coronary Angioplasty in people with Ischemia and Cardiac Death, run by JW Medical Systems Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Ge, Prof (+8613816112695, ge.lei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2009.