Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT (DM-COVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Harbin Medical University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 6-month ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. QCA parameters and IVUS parameters for binary restenosis, late lumen loss. [ Time Frame: 12-month ]
  11. TLR/TVR [ Time Frame: 12-month ]
  12. MACE [ Time Frame: 12-month ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General Inclusion Criteria：

  1. Age : 18-75Y
  2. Patients diagnosed as type 2 DM or non-DM.

Angiographic Inclusion Criteria：

  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:

General Exclusion Criteria：

  1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
  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.

Angiographic Exclusion Criteria：

  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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Bo Yu, MD,PhD 86-0451-86605180 yubodr@163.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Bo Yu, MD, PhD The Second Affiliated Hospital of Harbin Medical University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
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:
Layout table for MeSH terms
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Paclitaxel
 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