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

NCT01752582 | Completed DMC

• 1 other identifier: version1.1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

BuMA; EXCEL; OCT; stent; neointima formation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Neointimal hyperplasia area/volume

  three months after surgery

• Mean/Minimal Stent diameter/area/volume

  three months after surgery

• Mean/Minimal Lumen diameter/area/volume

  three months after surgery

• Mean/maximal thickness of the struts coverage

  three months after surgery

• Incomplete strut apposition

  three months after surgery

Study Arms (2)

BuMA stent

OTHER

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

EXCEL stent

OTHER

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

Interventions

BuMA stent DEVICE

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

BuMA stent

EXCEL stent DEVICE

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

EXCEL stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Coronary Disease; Angina, Stable; Angina, Unstable; Neointima

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Yang Y Jin, president

  Fuwai Hospital, Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

CN (1)