Assessment of Surface Coverage of Two Types of Drug-eluting Stent in Diabetes Mellitus and Non-Diabetes Mellitus
NCT ID: NCT01023919
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
120 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.
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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Group B:
Coronary artery disease without diabetes mellitus
Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Cypher stent or YinYi stent randomly implanted in coronary artery disease
Group A:
Coronary artery disease with diabetes mellitus
Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Cypher stent or YinYi stent randomly implanted in coronary artery disease
Interventions
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Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Cypher stent or YinYi stent randomly implanted in coronary artery disease
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 one significant (\>70%) angiographic stenosis lesions in native coronary vessel 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
Prof
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, Heilong Jiang, China
Countries
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Other Identifiers
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HMUOCT-DM vs NDM-2
Identifier Type: -
Identifier Source: org_study_id