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

Myocardial Infarction Clinical Trial

— EVOLUTION  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00825773
• Other study ID #: H-09-01-19
• Secondary ID: ZSH-20090119
• Status: Recruiting
• Phase: Phase 4
• First received: January 19, 2009
• Last updated: January 22, 2009
• Start date: October 2008
• Est. completion date: April 2014

Study information

• Verified date: January 2009
• Source: JW Medical Systems Ltd
• Contact: Lei Ge, Prof
• Phone: +8613816112695
• Email: ge.lei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1944
• Est. completion date: April 2014
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Death
• Ischemia
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
China	JW Medical Systems	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
JW Medical Systems Ltd

Country where clinical trial is conducted

China, 

References & Publications (1)

Salam AM, Al Suwaidi J, Holmes DR Jr. Drug-eluting coronary stents. Curr Probl Cardiol. 2006 Jan;31(1):8-119. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Rates of stent thrombosis		5 years	Yes
Secondary	Rates for each component of the TLF composite endpoint at 12 months post-procedure		5 years	Yes
Secondary	Major Adverse Cardiac Events (MACE) at 30 days, 6 months, 12 months and 2 to 5 years annually		5 years	Yes