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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01178268
First received: August 6, 2010
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Coronary Occlusion
Thrombosis (Stent Thrombosis)
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: XIENCE V EECSS
Device: CYPHER SELECT PLUS SECSS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • In-stent late loss (LL) [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    In-stent LL: in-stent Minimal Lumen Diameter (MLD) post procedure - in-stent MLD at follow-up

  • Ischemia-driven target vessel failure (ID-TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ischemia-driven target vessel revascularization (ID-TVR)

  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ID target vessel failure (ID-TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ID-TVR

  • ID target vessel failure (ID-TVF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI and ID-TVR

  • ID target vessel failure (ID-TVF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI, and ID-TVR

  • ID target vessel failure (ID-TVF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, all MI, and ID-TVR

  • ID target lesion failure (ID-TLF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  • ID target lesion failure (ID-TLF) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  • ID target lesion failure (ID-TLF) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  • ID target lesion failure (ID-TLF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of Stent thrombosis (ST)(Definite and probable), all death and all myocardial infarction (MI) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Patient compliance with DAPT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy

  • Patient compliance with DAPT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy

  • Patient compliance with DAPT [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy

  • Patient compliance with DAPT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy

  • Patient compliance with DAPT [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    DAPT: Dual Antiplatelet Therapy

  • Major bleeding complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Major bleeding complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of cardiac death and MI attributed to the target vessel [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of composite of all death (cardiac, vascular and non-cardiovascular) and all MI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • All revascularization (TLR, TVR, and non-TVR) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • All revascularization (TLR, TVR, and non-TVR) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • All revascularization (TLR, TVR, and non-TVR) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • All revascularization (TLR, TVR, and non-TVR) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • All revascularization (TLR, TVR, and non-TVR) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death (cardiac, vascular, non-cardiovascular) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • All MI (including Q-wave or non Q-wave) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death and all MI [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Acute device success [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Achievement of a final in-stent residual diameter stenosis of <50% using only the assigned device and without device malfunction.

  • XIENCE V EECSS acute performance and deliverability using the XIENCE V EECSS Performance Evaluation Questionnaire [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Procedure time [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Amount of contrast used [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.

  • ID target lesion failure (ID-TLF) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR

  • Acute procedure success [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    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.

  • Composite of all death, all MI, and all revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Composite of all death, all MI, and all revascularization [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 546
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XIENCE V EECSS
Patients who will receive this stent.
Device: XIENCE V EECSS
Patients who will receive this stent.
Active Comparator: CYPHER SELECT PLUS SECSS
Patients who will receive this stent.
Device: CYPHER SELECT PLUS SECSS
Patients who will receive this stent.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178268

Locations
China
Fu Wai Hospital
Beijing, China, 100037
Authorized Representative in China Guidant International Trading (Shanghai) Co., Ltd.
Shanghai, China, 200122
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Gao Runlin, MD, FACC Fu Wai Hospital
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01178268     History of Changes
Other Study ID Numbers: 10-387
Study First Received: August 6, 2010
Last Updated: June 9, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
Angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Occlusion
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Embolism and Thrombosis
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014