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

Primary Purpose

Coronary Artery Disease, Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Device: 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 Artery Disease focused on measuring Optical coherence tomography, Drug eluting stent, Coronary Artery 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 one significant (>70%) angiographic stenosis lesions in native coronary vessel 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 B: Non-DM

Group A: DM

Arm Description

Coronary artery disease with diabetes mellitus

Outcomes

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

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

To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation

To investigate the differences of surface coverage pattern，the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients

To investigate the differences of surface coverage pattern，malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients

Full Information

NCT ID

NCT01023919

First Posted

December 1, 2009

Last Updated

March 29, 2010

Sponsor

Harbin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01023919

Brief Title

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

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

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 Artery Disease, Diabetes Mellitus

Keywords

Optical coherence tomography, Drug eluting stent, Coronary Artery 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

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group B: Non-DM

Arm Type

Active Comparator

Arm Description

Coronary artery disease with diabetes mellitus

Arm Title

Group A: DM

Arm Type

Active Comparator

Arm Description

Coronary artery disease with diabetes mellitus

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

Cypher stent or YinYi stent randomly implanted in coronary artery disease

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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.

Title

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.

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 one significant (>70%) angiographic stenosis lesions in native coronary vessel 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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Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus

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