XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

NCT ID: NCT01178268

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-09-30

Brief Summary

This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.

Detailed Description

Objectives

• Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China
• Evaluate patient compliance with dual antiplatelet therapy (DAPT)
• Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization

Conditions

Coronary Occlusion; Thrombosis (Stent Thrombosis); Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

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

Study Groups

XIENCE V EECSS

Patients who will receive this stent.

Group Type: ACTIVE_COMPARATOR

XIENCE V EECSS

Intervention Type: DEVICE

Patients who will receive this stent.

CYPHER SELECT PLUS SECSS

Patients who will receive this stent.

Group Type: ACTIVE_COMPARATOR

CYPHER SELECT PLUS SECSS

Intervention Type: DEVICE

Patients who will receive this stent.

Interventions

XIENCE V EECSS

Patients who will receive this stent.

Intervention Type: DEVICE

CYPHER SELECT PLUS SECSS

Patients who will receive this stent.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient must be at least 18 years of age

2. The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure.

3. Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.

4. Patient must not currently be and must agree not to become a participant in any other clinical trial until completion of his/her 2-year follow-up.

1. Target lesion(s) must be located in a native de novo coronary artery with a visually estimated diameter between ≥ 2.25 and ≤ 4.0 mm.

2. Target lesion(s) must measure ≤ 28 mm in length by visual estimation.

3. A maximum of two de novo lesions can be treated, ie,

1. One lesion in one vessel, OR

2. One lesion in each of two vessels, OR

3. Two lesions in one vessel

Exclusion Criteria

1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure

2. Patients with known renal insufficiency or failure (eg, serum creatinine level of > 2.5 mg/dL, or patient is on dialysis)

3. Patient had an MI within 72 hours and creatine kinase-myocardial band isoenzyme (CK-MB) has not returned to the normal range at the index procedure

4. Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure

5. Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure

6. Left ventricular ejection fraction (LVEF) of < 30%.

7. Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year

8. Patient's current medical condition has a life expectancy of < 2 years

9. Patient meets contraindications of the IFU

1. Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft

2. Lesion located in left main coronary artery

3. Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)

4. Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation

5. Total occluded lesions (TIMI=0)

6. Restenotic lesions

7. Thrombus-containing vessel

8. Extreme angulation (≥ 90º) proximal to or within the lesion

9. Excessive tortuosity proximal to or within the lesion

10. Heavy calcification

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

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gao Runlin, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital

Locations

Fu Wai Hospital

Beijing, , China

Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.

Shanghai, , China

Countries

China

Other Identifiers

10-387

Identifier Type: -

Identifier Source: org_study_id