Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT

NCT01021930 | Terminated DMC

• 1 other identifier: HMUOCT-DM vs NDM-1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Diabetes Mellitus

Keywords

Optical coherence tomography; Drug eluting stent; Coronary heart disease; Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT.

  Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT.

  6-month

Secondary Outcomes (12)

• Comparison of troponin-I levels between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours after stent implantation

  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

  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

  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

  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

  6-month

Study Arms (2)

Group A: DM

ACTIVE COMPARATOR

Coronary artery disease with diabetes mellitus

Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)

Group B: Non-DM

ACTIVE COMPARATOR

Coronary artery disease without diabetes mellitus

Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)

Interventions

Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent) DEVICE

Polymer-based sirolimus-eluting stent( Cypher, Cordis ) and Polymer-free paclitaxel-eluting stent (YinYi ),randomly implanted in two vessels of one patients

Group A: DM; Group B: Non-DM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

The second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bo Yu, MD, PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (1)