Clinical trial NCT01178268: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Official title: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Occlusion
Thrombosis (Stent Thrombosis)
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: Drug eluting stents
Stents
Angioplasty
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-08-10
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: In-stent Late Loss (LL)
timeFrame: >=13 months
measure: Ischemia-driven Target Vessel Failure (ID-TVF)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
Secondary outcomes:
measure: Ischemia-driven Target Vessel Failure (ID-TVF)
timeFrame: 30 days
measure: Ischemia-driven Target Vessel Failure (ID-TVF)
timeFrame: 6 months
measure: Ischemia-driven Target Vessel Failure (ID-TVF)
timeFrame: 9 months
measure: Ischemia-driven Target Vessel Failure (ID-TVF)
timeFrame: 24 months
measure: 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).
timeFrame: 30 days
measure: 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).
timeFrame: 6 months
measure: 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)
timeFrame: 9 months
measure: 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)
timeFrame: 24 months
measure: Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
timeFrame: 12 months
measure: Ischemia-driven Target Lesion Failure (ID-TLF)
timeFrame: 30 days
measure: Ischemia-driven Target Lesion Failure (ID-TLF)
timeFrame: 6 months
measure: Ischemia-driven Target Lesion Failure (ID-TLF)
timeFrame: 9 months
measure: Ischemia-driven Target Lesion Failure (ID-TLF)
timeFrame: 12 months
measure: Ischemia-driven Target Lesion Failure (ID-TLF)
timeFrame: 24 months
measure: Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
timeFrame: 30 days
measure: Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
timeFrame: 6 months
measure: Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
timeFrame: 9 months
measure: Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
timeFrame: 12 months
measure: Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non-Q-wave) Attributed to the Target Vessel (TV)
timeFrame: 24 months
measure: All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
timeFrame: 30 days
measure: All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
timeFrame: 6 months
measure: All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
timeFrame: 9 months
measure: All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
timeFrame: 12 months
measure: All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)
timeFrame: 24 months
measure: Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
timeFrame: 30 days
measure: Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
timeFrame: 6 months
measure: Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
timeFrame: 9 months
measure: Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
timeFrame: 12 months
measure: Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI
timeFrame: 24 months
measure: Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
timeFrame: 30 days
measure: Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
timeFrame: 6 months
measure: Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
timeFrame: 9 months
measure: Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
timeFrame: 12 months
measure: Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)
timeFrame: 24 months
measure: All Revascularization (TLR, TVR, and Non-TVR)
timeFrame: 30 Days
measure: All Revascularization (TLR, TVR, and Non-TVR)
timeFrame: 6 Months
measure: All Revascularization (TLR, TVR, and Non-TVR)
timeFrame: 9 Months
measure: All Revascularization (TLR, TVR, and Non-TVR)
timeFrame: 12 months
measure: All Revascularization (TLR, TVR, and Non-TVR)
timeFrame: 24 months
measure: All Death
timeFrame: 30 days
measure: All Death
timeFrame: 6 months
measure: All Death
timeFrame: 9 months
measure: All Death
timeFrame: 12 months
measure: All Death
timeFrame: 24 months
measure: All Protocol MI (Including Q-wave or Non-Q-wave)
timeFrame: 30 days
measure: All Protocol MI (Including Q-wave or Non-Q-wave)
timeFrame: 6 months
measure: All Protocol MI (Including Q-wave or Non-Q-wave)
timeFrame: 9 months
measure: All Protocol MI (Including Q-wave or Non-Q-wave)
timeFrame: 12 months
measure: All Protocol MI (Including Q-wave or Non-Q-wave)
timeFrame: 24 months
measure: Target Vessel Protocol MI (TV-MI)
timeFrame: 30 days
measure: Target Vessel Protocol MI (TV-MI)
timeFrame: 6 months
measure: Target Vessel Protocol MI (TV-MI)
timeFrame: 9 months
measure: Target Vessel Protocol MI (TV-MI)
timeFrame: 12 months
measure: Target Vessel Protocol MI (TV-MI)
timeFrame: 24 months
measure: Major Bleeding Complications
timeFrame: 30 days
measure: Major Bleeding Complications
timeFrame: 6 months
measure: Major Bleeding Complications
timeFrame: 9 months
measure: Major Bleeding Complications
timeFrame: 12 months
measure: Major Bleeding Complications
timeFrame: 24 months
measure: Definite / Probable Stent Thrombosis
timeFrame: Acute (<1 day)
measure: Definite / Probable Stent Thrombosis
timeFrame: Subacute (1 - 30 days)
measure: Definite / Probable Stent Thrombosis
timeFrame: Early (0 - 30 days)
measure: Definite / Probable Stent Thrombosis
timeFrame: Late (31 - 365 days)
measure: Definite / Probable Stent Thrombosis
timeFrame: Very late (366 - 772 days)
measure: Definite / Probable Stent Thrombosis
timeFrame: Overall (0 - 772 days)
measure: Patient Compliance With Dual Antiplatelet Therapy (DAPT)
timeFrame: 30 days
measure: Patient Compliance With Dual Antiplatelet Therapy (DAPT)
timeFrame: 6 months
measure: Patient Compliance With Dual Antiplatelet Therapy (DAPT)
timeFrame: 9 months
measure: Patient Compliance With Dual Antiplatelet Therapy (DAPT)
timeFrame: 12 months
measure: Patient Compliance With Dual Antiplatelet Therapy (DAPT)
timeFrame: 24 months
measure: Acute Device Success
timeFrame: < or = 1 day
measure: Acute Procedure Success
timeFrame: < or = 1 day
measure: Procedure Time
timeFrame: On day 0, during the procedure.
measure: Amount of Contrast Used
timeFrame: On day 0, during the procedure.
measure: Fluoroscopy Time
timeFrame: On day 0, during the procedure.
measure: XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire
timeFrame: During the procedure
measure: Follow-up Late Loss
timeFrame: ≥13 months.
measure: Follow-up In-stent Minimum Lumen Diameter (MLD)
timeFrame: ≥13 months
measure: Follow-up In-stent Percent Diameter Stenosis (DS)
timeFrame: ≥13 months
measure: Follow-up In-stent Angiographic Binary Restenosis (ABR)
timeFrame: ≥13 months
measure: Follow-up In-segment Minimum Lumen Diameter (MLD)
timeFrame: ≥13 months
measure: Follow-up In-segment Percent Diameter Stenosis (DS)
timeFrame: ≥13 months
measure: Follow-up In-segment Angiographic Binary Restenosis (ABR)
timeFrame: ≥13 months
measure: Percent Diameter Stenosis
timeFrame: pre procedure
measure: Percent Diameter Stenosis (%DS)
timeFrame: post procedure on 0 day
measure: Acute Gain
timeFrame: post procedure on 0 day
Other outcomes:
measure: ID-TVF Rate in Patients With Diabetic Disease
timeFrame: 24 months
measure: ID-TVF Rate in Patients Without Diabetic Disease
timeFrame: 24 months
measure: ID-TVF Rate in Single Lesion Treated Subgroup
timeFrame: 24 months
measure: ID-TVF Rate in Dual Lesion Treated Subgroup
timeFrame: 24 months
measure: ID-TVF Rate in Single Vessel Treated Subgroup
timeFrame: 24 months
measure: ID-TVF Rate in Dual Vessel Treated Subgroup
timeFrame: 24 months
measure: The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.
timeFrame: 24 months
measure: The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease
timeFrame: 24 months
measure: The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup
timeFrame: 24 months
measure: The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup
timeFrame: 24 months
measure: The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup
timeFrame: 24 months
measure: The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup
timeFrame: 24 months
measure: ID-TLR Rate in Patients With Diabetic Disease.
timeFrame: 24 months
measure: ID-TLR Rate in Patients Without Diabetic Disease
timeFrame: 24 months
measure: ID-TLR Rate in Single Lesion Treated Subgroup
timeFrame: 24 months
measure: ID-TLR Rate in Dual Lesion Treated Subgroup
timeFrame: 24 months
measure: ID-TLR Rate in Single Vessel Treated Subgroup
timeFrame: 24 months
measure: ID-TLR Rate in Dual Vessel Treated Subgroup
timeFrame: 24 months
Locations:
city: Beijing
country: China
facility: Fu Wai Hospital
city: Shanghai
country: China
facility: Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
Study officials:
affiliation: Fu Wai Hospital
name: Gao Runlin, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: