Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT (DM-COVER)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Harbin Medical University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Harbin Medical University
Information provided by:
Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01021930
First received: November 30, 2009
Last updated: May 25, 2010
Last verified: December 2009
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Purpose
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 | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (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) |
Resource links provided by NLM:
Further study details as provided by Harbin Medical University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
- TLR/TVR [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
- MACE [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 70 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group A: DM
Coronary artery disease with 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
|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021930
Contacts
| Contact: Bo Yu, MD,PhD | 86-0451-86605180 | yubodr@163.com |
Locations
| 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 | |
Sponsors and Collaborators
Harbin Medical University
Investigators
| Principal Investigator: | Bo Yu, MD, PhD | The Second Affiliated Hospital of Harbin Medical University |
More Information
No publications provided
| 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 |
| Study First Received: | November 30, 2009 |
| Last Updated: | May 25, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Harbin Medical University:
|
Optical coherence tomography Drug eluting stent Coronary heart disease Diabetes mellitus |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sirolimus Paclitaxel Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013