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

NCT01178268 | Completed Phase 4 Results

• 1 other identifier: 10-387
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Drug eluting stents; Stents; Angioplasty

Outcome Measures

Primary Outcomes (3)

• In-stent Late Loss (LL)

  This is the primary angiographic endpoint. In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)

  >=13 months

• Ischemia-driven Target Vessel Failure (ID-TVF)

  This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).

  12 months

• Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave)

  The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non-Q-wave).

  12 months

Secondary Outcomes (86)

• Ischemia-driven Target Vessel Failure (ID-TVF)

  30 days

• Ischemia-driven Target Vessel Failure (ID-TVF)

  6 months

• Ischemia-driven Target Vessel Failure (ID-TVF)

  9 months

• Ischemia-driven Target Vessel Failure (ID-TVF)

  24 months

• Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non-Q-wave).

  30 days

Other Outcomes (18)

• ID-TVF Rate in Patients With Diabetic Disease

  24 months

• ID-TVF Rate in Patients Without Diabetic Disease

  24 months

• ID-TVF Rate in Single Lesion Treated Subgroup

  24 months

Study Arms (2)

XIENCE V EECSS

ACTIVE COMPARATOR

Patients who will receive this stent.

Device: XIENCE V EECSS

CYPHER SELECT PLUS SECSS

ACTIVE COMPARATOR

Patients who will receive this stent.

Device: CYPHER SELECT PLUS SECSS

Interventions

XIENCE V EECSS DEVICE

Patients who will receive this stent.

XIENCE V EECSS

CYPHER SELECT PLUS SECSS DEVICE

Patients who will receive this stent.

CYPHER SELECT PLUS SECSS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be at least 18 years of age
• 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.
• Patient must agree to undergo all protocol-required follow-ups until the completion of his/her 2-year follow-up.
• 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.
• 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.
• Target lesion(s) must measure ≤ 28 mm in length by visual estimation.
• A maximum of two de novo lesions can be treated, ie,
• One lesion in one vessel, OR
• One lesion in each of two vessels, OR
• Two lesions in one vessel

You may not qualify if:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year post index procedure
• Patients with known renal insufficiency or failure (eg, serum creatinine level of \> 2.5 mg/dL, or patient is on dialysis)
• 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
• Non-study PCI for lesions in a target vessel (including side branches) has been performed within 1 year prior to the index procedure
• Patient has a planned PCI (staged procedure) within 6 months from the date of the index procedure
• Left ventricular ejection fraction (LVEF) of \< 30%.
• Any planned surgery necessitating discontinuation of antiplatelet therapy within 1 year
• Patient's current medical condition has a life expectancy of \< 2 years
• Patient meets contraindications of the IFU
• Lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
• Lesion located in left main coronary artery
• Ostial lesion (within 3 mm of the aorta junction, or origin of the left anterior descending or left circumflex arteries)
• 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
• Total occluded lesions (TIMI=0)
• Restenotic lesions

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Fu Wai Hospital

Beijing, 100037, China

Location

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

Shanghai, 200122, China

Location

MeSH Terms

Conditions

Coronary Occlusion; Thrombosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Dana Haudek
• Organization: Abbott Vascular

dana.haudek@av.abbott.com

928-925-4054

Study Officials

• Gao Runlin, MD, FACC

  Fu Wai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 10, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: September 1, 2014
• Last Updated: August 24, 2016
• Results First Posted: August 24, 2016

Record last verified: 2016-07

Locations

CN (2)