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

Diabetes Mellitus Clinical Trial

— DM-COVER  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01021930
• Other study ID #: HMUOCT-DM vs NDM-1
• Status: Recruiting
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: May 25, 2010
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2009
• Source: Harbin Medical University
• Contact: Bo Yu, MD,PhD
• Phone: 86-0451-86605180
• Email: yubodr[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes Mellitus
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	The second Affiliated Hospital of Harbin Medical University	Harbin	Heilong jiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the surface coverage between DM and Non-DM at 6 months after Cypher and YINYI stent implantation using OCT.		6-month	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	QCA parameters and IVUS parameters for binary restenosis, late lumen loss.		6-month	Yes
Secondary	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		12-month	Yes
Secondary	Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT		12-month	Yes
Secondary	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		12-month	Yes
Secondary	QCA parameters and IVUS parameters for binary restenosis, late lumen loss.		12-month	Yes
Secondary	TLR/TVR		12-month	Yes
Secondary	MACE		12-month	Yes