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

Coronary Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752582
• Other study ID #: version1.1
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: March 10, 2016
• Start date: December 2012

Study information

• Verified date: March 2016
• Source: Sino Medical Sciences Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Neointima
• Silent Myocardial Ischemia
• Stable Angina Pectoris
• Unstable Angina Pectoris

Intervention

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

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Science	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sino Medical Sciences Technology Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Incomplete strut apposition	It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment.	three months after surgery	No
Secondary	Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months		three months after surgery	Yes
Secondary	Late Lumen Loss at 3 months		three months after surgery	Yes
Secondary	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	Yes
Secondary	Acute success rate	It includes the device success,lesion success and procedural success.	up to 7 days after surgery	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Stent thrombosis according to the ARC definitions at 3 months		three months after surgery	Yes
Secondary	Stent thrombosis according to the ARC definitions at 6 months		six months after surgery	Yes
Secondary	Stent thrombosis according to the ARC definitions at 1 year		one year after surgery	Yes
Secondary	Stent thrombosis according to the ARC definitions at 2 years		2 years after surgery	Yes