Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT
NCT ID: NCT01021930
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
70 participants
INTERVENTIONAL
2009-11-30
2010-12-31
Brief Summary
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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.
Detailed Description
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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 .
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Group A: DM
Coronary artery disease with diabetes mellitus
Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Polymer-based sirolimus-eluting stent( Cypher, Cordis ) and Polymer-free paclitaxel-eluting stent (YinYi ),randomly implanted in two vessels of one patients
Group B: Non-DM
Coronary artery disease without diabetes mellitus
Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Polymer-based sirolimus-eluting stent( Cypher, Cordis ) and Polymer-free paclitaxel-eluting stent (YinYi ),randomly implanted in two vessels of one patients
Interventions
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Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Polymer-based sirolimus-eluting stent( Cypher, Cordis ) and Polymer-free paclitaxel-eluting stent (YinYi ),randomly implanted in two vessels of one patients
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed as type 2 DM or non-DM.
1. Patients were considered eligible if they have two significant (\>70%) angiographic stenosis lesions in different native coronary vessels by CAG.
2. Each target is de novo lesion that can be treated with 1-2 stents.
3. Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion Criteria
2. Life expectancy \<12 months due to another medical condition.
3. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
4. Creatinine level more than 2.0mg/dL or ESRD.
5. Severe hepatic dysfunction (more than 3 times normal reference values).
6. Planned surgery procedure≤12 months post-index procedure.
7. Known allergy to stainless steel.
8. 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.
9. Patient is not clinically appropriate for OCT evaluation in the opinion of investigator.
1. Study lesion is ostial in location (within 3.0 mm of vessel origin).
2. Study lesion involving arterial segments with highly tortuous anatomy.
3. Complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).
18 Years
75 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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Yu Bo
MD, PhD
Principal Investigators
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Bo Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Harbin Medical University
Locations
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The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Countries
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Other Identifiers
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HMUOCT-DM vs NDM-1
Identifier Type: -
Identifier Source: org_study_id