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

Primary Purpose

Coronary Heart Disease, Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Optical coherence tomography, Drug eluting stent, Coronary heart disease, Diabetes mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

General Inclusion Criteria：

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

Angiographic Inclusion Criteria：

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.

Exclusion Criteria:

General Exclusion Criteria：

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.

Angiographic Exclusion Criteria：

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).

Sites / Locations

The second Affiliated Hospital of Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A: DM

Group B: Non-DM

Arm Description

Coronary artery disease with diabetes mellitus

Coronary artery disease without diabetes mellitus

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Comparison of hsCRP concentration between DM and Non-DM at baseline, 8 hours, 16 hours and 24 hours 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

Comparison of surface coverage, late stent malapposition, neointimal heterogeneity and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT

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

QCA parameters and IVUS parameters for binary restenosis, late lumen loss.

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

Comparison of surface coverage, late stent malapposition, neointimal heterogeneity, and the incidence of thrombosis between Cypher and YINYI in DM after stenting using OCT

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

QCA parameters and IVUS parameters for binary restenosis, late lumen loss.

TLR/TVR

MACE

Full Information

NCT ID

NCT01021930

First Posted

November 30, 2009

Last Updated

May 25, 2010

Sponsor

Harbin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01021930

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Harbin Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease, Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: DM

Arm Type

Active Comparator

Arm Description

Coronary artery disease with diabetes mellitus

Arm Title

Group B: Non-DM

Arm Type

Active Comparator

Arm Description

Coronary artery disease without diabetes mellitus

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

QCA parameters and IVUS parameters for binary restenosis, late lumen loss.

Time Frame

6-month

Title

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

Title

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

Title

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

Title

QCA parameters and IVUS parameters for binary restenosis, late lumen loss.

Time Frame

12-month

Title

TLR/TVR

Time Frame

12-month

Title

MACE

Time Frame

12-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: General Inclusion Criteria： Age : 18-75Y Patients diagnosed as type 2 DM or non-DM. Angiographic Inclusion Criteria： 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. Exclusion Criteria: General Exclusion Criteria： 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. Angiographic Exclusion Criteria： 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Yu, MD,PhD

Phone

86-0451-86605180

yubodr@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD, PhD

Organizational Affiliation

The Second Affiliated Hospital of Harbin Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The second Affiliated Hospital of Harbin Medical University

City

Harbin

State/Province

Heilong jiang

ZIP/Postal Code

150081

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD, PhD

Phone

86-0451-86605180

yubodr@163.com

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD.PhD

12. IPD Sharing Statement

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

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