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

This study is not yet open for participant recruitment.
Verified December 2012 by Sino Medical Sciences Technology Inc.
Sponsor:
Information provided by (Responsible Party):
Sino Medical Sciences Technology Inc.
ClinicalTrials.gov Identifier:
NCT01752582
First received: December 7, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Stable Angina Pectoris
Unstable Angina Pectoris
Silent Myocardial Ischemia
Device: BuMA stent
Device: EXCEL stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sino Medical Sciences Technology Inc.:

Primary Outcome Measures:
  • the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment. [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.


Secondary Outcome Measures:
  • Neointimal hyperplasia area/volume [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment.

  • Mean/Minimal Stent diameter/area/volume [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment.

  • Mean/Minimal Lumen diameter/area/volume [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment.

  • Mean/maximal thickness of the struts coverage [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment.

  • Incomplete strut apposition [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment.

  • Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months [ Time Frame: three months after surgery ] [ Designated as safety issue: Yes ]
  • Late Lumen Loss at 3 months [ Time Frame: three months after surgery ] [ Designated as safety issue: Yes ]
  • Binary Restenosis (DS ≥50%) at 3 months [ Time Frame: three months after surgery ] [ Designated as safety issue: Yes ]
    All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.

  • Acute success rate [ Time Frame: up to 7 days after surgery ] [ Designated as safety issue: Yes ]
    It includes the device success,lesion success and procedural success.

  • Device-oriented Composite Endpoints and its individual components at 3 months [ Time Frame: three months after surgery ] [ Designated as safety issue: Yes ]
    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.

  • Device-oriented Composite Endpoints and its individual components at 6 months [ Time Frame: six months after surgery ] [ Designated as safety issue: Yes ]
    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.

  • Device-oriented Composite Endpoints and its individual components at 1 year [ Time Frame: one year after surgery ] [ Designated as safety issue: Yes ]
    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.

  • Device-oriented Composite Endpoints and its individual components at 2 years [ Time Frame: 2 years after surgery ] [ Designated as safety issue: Yes ]
    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.

  • Stent thrombosis according to the ARC definitions at 3 months [ Time Frame: three months after surgery ] [ Designated as safety issue: Yes ]
  • Stent thrombosis according to the ARC definitions at 6 months [ Time Frame: six months after surgery ] [ Designated as safety issue: Yes ]
  • Stent thrombosis according to the ARC definitions at 1 year [ Time Frame: one year after surgery ] [ Designated as safety issue: Yes ]
  • Stent thrombosis according to the ARC definitions at 2 years [ Time Frame: 2 years after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752582

Contacts
Contact: Yang Y Jin, president (86-10)88398760 yangyjfw@yahoo.com.cn
Contact: Xu Bo, director (86-10)88398638 bxu@cit.com

Locations
China, Beijing
Fuwai Hospital, Chinese Academy of Medical Science Not yet recruiting
BeiJing, Beijing, China, 100037
Contact: Yang Y Jin, president    (86-10) 88398760    yangyjfw@yahoo.com.cn   
Contact: Xu Bo, director    (86-10) 88398638    bxu@cit.com   
Principal Investigator: Yang Y Jin, president         
Sponsors and Collaborators
Sino Medical Sciences Technology Inc.
Investigators
Principal Investigator: Yang Y Jin, president Fuwai Hospital, Chinese Academy of Medical Science
  More Information

No publications provided

Responsible Party: Sino Medical Sciences Technology Inc.
ClinicalTrials.gov Identifier: NCT01752582     History of Changes
Other Study ID Numbers: version1.1
Study First Received: December 7, 2012
Last Updated: December 19, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sino Medical Sciences Technology Inc.:
BuMA
EXCEL
OCT
stent
neointima formation

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Ischemia
Neointima
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014