Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT (DM-COVER)
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ClinicalTrials.gov Identifier: NCT01021930 |
Recruitment Status
: Unknown
Verified December 2009 by Harbin Medical University.
Recruitment status was: Recruiting
First Posted
: December 1, 2009
Last Update Posted
: May 26, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease Diabetes Mellitus | Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for Surface Coverage After Two Types of Drug-eluting Stent Implantation (A Pilot Study) |
Study Start Date : | November 2009 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | June 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Group A: DM
Coronary artery disease with diabetes mellitus
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Device: 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
|
Active Comparator: Group B: Non-DM
Coronary artery disease without diabetes mellitus
|
Device: 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
|
- Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT. [ Time Frame: 6-month ]
- Comparison of troponin-I levels between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation [ Time Frame: at every 8-hour in first 24-hour after stent implantation ]
- Comparison of hsCRP concentration between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation [ Time Frame: at every 8-hour in first 24-hour after stent implantation ]
- Comparison of the malapposition, neointimal heterogeneity and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT [ Time Frame: 6-month ]
- Comparison of surface coverage, late stent malapposition, neointimal heterogeneity and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT [ Time Frame: 6-month ]
- Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in Non-DM after stenting using OCT [ Time Frame: 6-month ]
- QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 6-month ]
- Comparison of the surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between DM and Non-DM patients after Cypher and YINYI implantation using OCT [ Time Frame: 12-month ]
- Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT [ Time Frame: 12-month ]
- Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in Non-DM after stenting using OCT [ Time Frame: 12-month ]
- QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 12-month ]
- TLR/TVR [ Time Frame: 12-month ]
- MACE [ Time Frame: 12-month ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 two significant (>70%) angiographic stenosis lesions in different native coronary vessels 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021930
Contact: Bo Yu, MD,PhD | 86-0451-86605180 | yubodr@163.com |
China, Heilong jiang | |
The second Affiliated Hospital of Harbin Medical University | Recruiting |
Harbin, Heilong jiang, China, 150081 | |
Contact: Bo Yu, MD, PhD 86-0451-86605180 yubodr@163.com | |
Principal Investigator: Bo Yu, MD.PhD |
Principal Investigator: | Bo Yu, MD, PhD | The Second Affiliated Hospital of Harbin Medical University |
Responsible Party: | Bo Yu, Department of Cardiology of The Second Affiliated Hospital of Harbin Medical University |
ClinicalTrials.gov Identifier: | NCT01021930 History of Changes |
Other Study ID Numbers: |
HMUOCT-DM vs NDM-1 |
First Posted: | December 1, 2009 Key Record Dates |
Last Update Posted: | May 26, 2010 |
Last Verified: | December 2009 |
Keywords provided by Harbin Medical University:
Optical coherence tomography Drug eluting stent Coronary heart disease Diabetes mellitus |
Additional relevant MeSH terms:
Diabetes Mellitus Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Paclitaxel Sirolimus |
Everolimus Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |