Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus
Primary Purpose
Coronary Artery Disease, Diabetes Mellitus
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Optical coherence tomography, Drug eluting stent, Coronary Artery Disease, Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria
General Inclusion Criteria:
- Age : 18-75Y
- Patients diagnosed as type 2 DM or non-DM.
Angiographic Inclusion Criteria:
- Patients were considered eligible if they have one significant (>70%) angiographic stenosis lesions in native coronary vessel by CAG.
- Each target is de novo lesion that can be treated with 1-2 stents.
- Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion Criteria
General Exclusion Criteria:
- ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
- Life expectancy <12 months due to another medical condition.
- Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
- Creatinine level more than 2.0mg/dL or ESRD.
- Severe hepatic dysfunction (more than 3 times normal reference values).
- Planned surgery procedure≤12 months post-index procedure.
- Known allergy to stainless steel.
- Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
- Patient is not clinically appropriate for OCT evaluation in the opinion of investigator.
Angiographic Exclusion Criteria:
- Study lesion is ostial in location (within 3.0 mm of vessel origin).
- Study lesion involving arterial segments with highly tortuous anatomy.
- Complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).
Sites / Locations
- The second Affiliated Hospital of Harbin Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group B: Non-DM
Group A: DM
Arm Description
Coronary artery disease with diabetes mellitus
Coronary artery disease with diabetes mellitus
Outcomes
Primary Outcome Measures
To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent)implantation
Secondary Outcome Measures
To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
To investigate the differences of surface coverage pattern,the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients
To investigate the differences of surface coverage pattern,malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients
Full Information
NCT ID
NCT01023919
First Posted
December 1, 2009
Last Updated
March 29, 2010
Sponsor
Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01023919
Brief Title
Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus
Official Title
Assessment of Surface Coverage of Polymer-based Sirolimus-eluting Stent( Cypher ) or Polymer-free Paclitaxel-eluting Stent (YinYi )in Diabetes Mellitus and Non- Diabetes Mellitus Patients by Optical Coherence Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Harbin Medical University
4. Oversight
5. Study Description
Brief Summary
Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis. Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI) are poor in patients with DM compared with those without DM. Autopsy study has shown delayed neointimal healing with inadequate endothelialization and persistent stent surface fibrin deposition after DES implantation in DM patients. This might partially contribute to the high risk of late stent thrombosis.
YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with micro porous surface. However, limited data is available in vivo about the surface coverage after stent implantation in DM patients because of lack of sensitive imaging modalities. Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound(IVUS)that allows high-resolution tomographic intravascular imaging. Furthermore, several studies have demonstrated the feasibility of OCT to quantitatively evaluate the surface coverage and stent conditions in the follow up after PCI .
Therefore, the aim of this study was to analyze the surface coverage and late malapposition after two types of DES implantation in DM patients compared with non-DM patients by using OCT and IVUS
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes Mellitus
Keywords
Optical coherence tomography, Drug eluting stent, Coronary Artery Disease, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group B: Non-DM
Arm Type
Active Comparator
Arm Description
Coronary artery disease with diabetes mellitus
Arm Title
Group A: DM
Arm Type
Active Comparator
Arm Description
Coronary artery disease with diabetes mellitus
Intervention Type
Device
Intervention Name(s)
Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Intervention Description
Cypher stent or YinYi stent randomly implanted in coronary artery disease
Primary Outcome Measure Information:
Title
To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent)implantation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Time Frame
12 months
Title
To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Time Frame
6 months
Title
To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Time Frame
12 months
Title
To investigate the differences of surface coverage pattern,the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients
Time Frame
6 and 12 months.
Title
To investigate the differences of surface coverage pattern,malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients
Time Frame
6 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
General Inclusion Criteria:
Age : 18-75Y
Patients diagnosed as type 2 DM or non-DM.
Angiographic Inclusion Criteria:
Patients were considered eligible if they have one significant (>70%) angiographic stenosis lesions in native coronary vessel by CAG.
Each target is de novo lesion that can be treated with 1-2 stents.
Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion Criteria
General Exclusion Criteria:
ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
Life expectancy <12 months due to another medical condition.
Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
Creatinine level more than 2.0mg/dL or ESRD.
Severe hepatic dysfunction (more than 3 times normal reference values).
Planned surgery procedure≤12 months post-index procedure.
Known allergy to stainless steel.
Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
Patient is not clinically appropriate for OCT evaluation in the opinion of investigator.
Angiographic Exclusion Criteria:
Study lesion is ostial in location (within 3.0 mm of vessel origin).
Study lesion involving arterial segments with highly tortuous anatomy.
Complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Yu, MD, PhD
Phone
86-0451-86605180
Email
yubodr@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yu, MD,PhD
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilong jiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Yu, MD,PhD
Phone
86-0451-86605180
Email
yubodr@163.com
First Name & Middle Initial & Last Name & Degree
Bo Yu, MD, PhD
12. IPD Sharing Statement
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Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus
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