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

BuMA OCT Study(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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Stable Angina Pectoris; Unstable Angina Pectoris; Silent Myocardial Ischemia
• Intervention / Treatment: Device: BuMA stent; Device: EXCEL stent

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • BeiJing, Beijing, China, 100037
      • Fuwai Hospital, Chinese Academy of Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

OCT exclusion criteria

• 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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: BuMA stent; About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.
Other: 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.	Device: EXCEL stent; About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.	The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.	three months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neointimal hyperplasia area/volume	It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment.	three months after surgery
Mean/Minimal Stent diameter/area/volume	It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment.	three months after surgery
Mean/Minimal Lumen diameter/area/volume	It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment.	three months after surgery
Mean/maximal thickness of the struts coverage	It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment.	three months after surgery
Incomplete strut apposition	It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment.	three months after surgery
Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months		three months after surgery
Late Lumen Loss at 3 months		three months after surgery
Binary Restenosis (DS ≥50%) at 3 months	All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.	three months after surgery
Acute success rate	It includes the device success,lesion success and procedural success.	up to 7 days after surgery
Device-oriented Composite Endpoints and its individual components at 3 months	Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, Myocardial Infarction(MI) not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.	three months after surgery
Device-oriented Composite Endpoints and its individual components at 6 months	Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.	six months after surgery
Device-oriented Composite Endpoints and its individual components at 1 year	Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.	one year after surgery
Device-oriented Composite Endpoints and its individual components at 2 years	Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.	2 years after surgery
Stent thrombosis according to the ARC definitions at 3 months		three months after surgery
Stent thrombosis according to the ARC definitions at 6 months		six months after surgery
Stent thrombosis according to the ARC definitions at 1 year		one year after surgery
Stent thrombosis according to the ARC definitions at 2 years		2 years after surgery

Collaborators and Investigators

• Sponsor: Sino Medical Sciences Technology Inc.
• Investigators: Principal Investigator: Yang Y Jin, president, Fuwai Hospital, Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: OCT; stent; BuMA; EXCEL; neointima formation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Angina Pectoris; Angina, Stable; Angina, Unstable; Neointima
• Other Study ID Numbers: version1.1