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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178268
• Other study ID #: 10-387
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2010
• Last updated: November 4, 2014
• Start date: August 2010
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: September 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• General 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.

Angiographic Inclusion Criteria

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:

• General 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

Angiographic Exclusion Criteria

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• XIENCE V EECSS
Patients who will receive this stent.
• CYPHER SELECT PLUS SECSS
Patients who will receive this stent.

Locations

Country	Name	City	State
China	Fu Wai Hospital	Beijing
China	Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late loss (LL)	In-stent LL: in-stent Minimal Lumen Diameter (MLD) post procedure - in-stent MLD at follow-up	13 months	No
Primary	Ischemia-driven target vessel failure (ID-TVF)	Incidence of composite of cardiac death, all MI and ischemia-driven target vessel revascularization (ID-TVR)	12 months	Yes
Primary	Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI)		12 months	Yes
Secondary	ID target vessel failure (ID-TVF)	Incidence of composite of cardiac death, all MI and ID-TVR	30 days	Yes
Secondary	ID target vessel failure (ID-TVF)	Incidence of composite of cardiac death, all MI and ID-TVR	6 months	Yes
Secondary	ID target vessel failure (ID-TVF)	Incidence of composite of cardiac death, all MI, and ID-TVR	9 months	Yes
Secondary	ID target vessel failure (ID-TVF)	Incidence of composite of cardiac death, all MI, and ID-TVR	24 months	Yes
Secondary	ID target lesion failure (ID-TLF)	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR	30 days	Yes
Secondary	ID target lesion failure (ID-TLF)	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR	6 months	Yes
Secondary	ID target lesion failure (ID-TLF)	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR	9 months	Yes
Secondary	ID target lesion failure (ID-TLF)	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR	12 months	Yes
Secondary	Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI)		30 days	Yes
Secondary	Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI)		6 months	Yes
Secondary	Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI)		9 months	Yes
Secondary	Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI)		24 months	Yes
Secondary	Patient compliance with DAPT	DAPT: Dual Antiplatelet Therapy	30 days	No
Secondary	Patient compliance with DAPT	DAPT: Dual Antiplatelet Therapy	6 months	No
Secondary	Patient compliance with DAPT	DAPT: Dual Antiplatelet Therapy	9 months	No
Secondary	Patient compliance with DAPT	DAPT: Dual Antiplatelet Therapy	12 months	No
Secondary	Patient compliance with DAPT	DAPT: Dual Antiplatelet Therapy	24 months	No
Secondary	Major bleeding complications		30 days	Yes
Secondary	Major bleeding complications		6 months	Yes
Secondary	Major bleeding complications		9 months	Yes
Secondary	Major bleeding complications		12 months	Yes
Secondary	Major bleeding complications		24 months	Yes
Secondary	Incidence of composite of cardiac death and MI attributed to the target vessel		30 days	Yes
Secondary	Incidence of composite of cardiac death and MI attributed to the target vessel		6 months	Yes
Secondary	Incidence of composite of cardiac death and MI attributed to the target vessel		9 months	Yes
Secondary	Incidence of composite of cardiac death and MI attributed to the target vessel		12 months	Yes
Secondary	Incidence of composite of cardiac death and MI attributed to the target vessel		24 months	Yes
Secondary	Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI		30 days	No
Secondary	Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI		6 months	No
Secondary	Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI		9 months	No
Secondary	Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI		12 months	No
Secondary	Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI		24 months	No
Secondary	All revascularization (TLR, TVR, and non-TVR)		30 Days	Yes
Secondary	All revascularization (TLR, TVR, and non-TVR)		6 Months	Yes
Secondary	All revascularization (TLR, TVR, and non-TVR)		9 Months	Yes
Secondary	All revascularization (TLR, TVR, and non-TVR)		12 months	Yes
Secondary	All revascularization (TLR, TVR, and non-TVR)		24 months	Yes
Secondary	Death (cardiac, vascular, non-cardiovascular)		30 Days	Yes
Secondary	Death (cardiac, vascular, non-cardiovascular)		6 months	Yes
Secondary	Death (cardiac, vascular, non-cardiovascular)		9 Months	Yes
Secondary	Death (cardiac, vascular, non-cardiovascular)		12 months	Yes
Secondary	Death (cardiac, vascular, non-cardiovascular)		24 months	Yes
Secondary	All MI (including Q-wave or non Q-wave)		30 Days	Yes
Secondary	All MI (including Q-wave or non Q-wave)		6 Months	Yes
Secondary	All MI (including Q-wave or non Q-wave)		9 Months	Yes
Secondary	All MI (including Q-wave or non Q-wave)		12 months	Yes
Secondary	All MI (including Q-wave or non Q-wave)		24 months	Yes
Secondary	Death and all MI		30 Days	Yes
Secondary	Death and all MI		6 Months	Yes
Secondary	Death and all MI		9 Months	Yes
Secondary	Death and all MI		12 months	Yes
Secondary	Death and all MI		24 months	Yes
Secondary	Acute device success	Achievement of a final in-stent residual diameter stenosis of <50% using only the assigned device and without device malfunction.	During the procedure	No
Secondary	XIENCE V EECSS acute performance and deliverability using the XIENCE V EECSS Performance Evaluation Questionnaire		During the procedure	No
Secondary	Procedure time		During the procedure	No
Secondary	Fluoroscopy time		During the procedure	No
Secondary	Amount of contrast used	Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.	During the procedure	No
Secondary	ID target lesion failure (ID-TLF)	Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR	24 months	Yes
Secondary	Acute procedure success	Achievement of a final in-stent residual diameter stenosis of <50% using the assigned device and with any adjunctive devices and without cardiac death, MI or TVR.	During the procedure	No
Secondary	Composite of all death, all MI, and all revascularization		30 days	Yes
Secondary	Composite of all death, all MI, and all revascularization		6 months	Yes
Secondary	Composite of all death, all MI, and all revascularization		9 months	Yes
Secondary	Composite of all death, all MI, and all revascularization		12 months	Yes
Secondary	Composite of all death, all MI, and all revascularization		24 months	Yes