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

December 1, 2009
March 29, 2010
November 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01023919 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • 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 B: Non-DM
    Coronary artery disease with diabetes mellitus
    Intervention: Device: Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
  • Active Comparator: Group A: DM
    Coronary artery disease with diabetes mellitus
    Intervention: Device: Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2011
December 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
No
Contact: Bo Yu, MD, PhD 86-0451-86605180 yubodr@163.com
China
 
NCT01023919
HMUOCT-DM vs NDM-2
Not Provided
Bo Yu, Department of Cardiology of The Second Affiliated Hospital of Harbin Medical University
Harbin Medical University
Not Provided
Principal Investigator: Bo Yu, MD,PhD The Second Affiliated Hospital of Harbin Medical University
Harbin Medical University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP