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

Abbott

Status and phase: Completed; Phase 4

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

Treatments: Device: CYPHER SELECT PLUS SECSS; Device: XIENCE V EECSS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01178268

10-387

Details and patient eligibility

About

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.

Full 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

Enrollment: 546 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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546 participants in 2 patient groups

XIENCE V EECSS

Active Comparator group

Description:

Patients who will receive this stent.

Treatment:

Device: XIENCE V EECSS

CYPHER SELECT PLUS SECSS

Active Comparator group

Description:

Patients who will receive this stent.

Treatment:

Device: CYPHER SELECT PLUS SECSS