Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus

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
Sponsor:
Information provided by:
Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01023919
First received: December 1, 2009
Last updated: March 29, 2010
Last verified: December 2009
  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 Artery Disease
Diabetes Mellitus
Device: 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: Assessment of Surface Coverage of Polymer-based Sirolimus-eluting Stent( Cypher ) or Polymer-free Paclitaxel-eluting Stent (YinYi )in Diabetes Mellitus and Non- Diabetes Mellitus Patients by Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Harbin Medical University:

Primary Outcome Measures:
  • To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent)implantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To investigate the differences of surface coverage pattern,the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients [ Time Frame: 6 and 12 months. ] [ Designated as safety issue: Yes ]
  • To investigate the differences of surface coverage pattern,malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients [ Time Frame: 6 and 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
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 B: Non-DM
Coronary artery disease with diabetes mellitus
Device: 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
Active Comparator: Group A: DM
Coronary artery disease with diabetes mellitus
Device: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023919

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: NCT01023919     History of Changes
Other Study ID Numbers: HMUOCT-DM vs NDM-2
Study First Received: December 1, 2009
Last Updated: March 29, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Harbin Medical University:
Optical coherence tomography
Drug eluting stent
Coronary Artery 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
Everolimus
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 July 24, 2014