Loading clinical trials...

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT01178268•Abbott Medical Devices

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (2)

Fu Wai Hospital

Beijing, China

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

Shanghai, China

Key Dates

Start Date

August 1, 2010

Primary Completion Date

October 1, 2012

Completion Date

September 1, 2014

Last Updated

August 24, 2016

Enrollment

546

ACTUAL participants

Conditions

Coronary OcclusionThrombosis (Stent Thrombosis)Vascular DiseaseMyocardial IschemiaCoronary Artery StenosisCoronary DiseaseCoronary Artery DiseaseCoronary Restenosis

Interventions

XIENCE V EECSS

DEVICE

CYPHER SELECT PLUS SECSS

DEVICE

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

View study

RECRUITINGPHASE2

Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

NCT03372733

Cardiovascular Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Dietary Omega-7 Palmitoleic Acid-Rich Oil on Lipoprotein Metabolism and Satiety in Adults

The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

CLEANer Aspiration for Pulmonary Embolism