BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)

NCT ID: NCT01752582

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31

Brief Summary

The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.

This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.

Detailed Description

About 70 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).

All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months (including angiographic/OCT investigation), 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.

Conditions

Coronary Heart Disease; Stable Angina Pectoris; Unstable Angina Pectoris; Silent Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

BuMA stent

This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio).

BuMA stent Arm:About 35 patients will undergoing implantation of BuMA stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints.

Group Type: OTHER

BuMA stent

Intervention Type: DEVICE

About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.

EXCEL stent

This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio).

EXCEL stent Arm:About 35 patients will undergoing implantation of EXCEL stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints.

Group Type: OTHER

EXCEL stent

Intervention Type: DEVICE

About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.

Interventions

BuMA stent

About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.

Intervention Type: DEVICE

EXCEL stent

About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 to 85 years.
• Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
• The patient has a planned intervention of up to four de novo lesions, in different epicardial vessels.
• Lesion(s) must have a visually estimated diameter stenosis of ≥50% and <100%.
• Reference Vessel Diameter(RVD) must be between 2.5-4.0 mm
• Written informed consent.
• The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT controls at 3 months.

Exclusion Criteria

• Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
• Left ventricular ejection fraction(LVEF) <30%.
• Documented or suspected liver disease (including laboratory evidence of hepatitis).
• Known renal insufficiency (e.g. estimated glomerular filtration rate(eGFR) <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis).
• History of bleeding diathesis or coagulopathy.
• The patient is a recipient of a heart transplant.
• Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and ticlopidine), sirolimus or stainless steel.
• Other medical illness (e.g. cancer, neurological deficiency) or known history of substance abuse (alcohol etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives

• Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
• Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sino Medical Sciences Technology Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Y Jin, president

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, Chinese Academy of Medical Science

Locations

Fuwai Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

version1.1

Identifier Type: -

Identifier Source: org_study_id