DXR Stent for Vascular Healing and Thrombus Formation: OC... | NCT02932995

Studies
DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

NCT02932995

Sponsor

Chung-Ang University

Status

Unknown status

Last Update Posted

Oct 19, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Coronary Artery Disease
Coronary Stent Occlusion

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 12, 2016

First Posted Date

Oct 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2016

Last Update Posted Date

Oct 19, 2016Estimated

Name	Class
Konyang University Hospital	OTHER
Kyunghee University Medical Center	OTHER
Korea University Guro Hospital	OTHER
Ulsan University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage, malapposition, and thrombus formation, assessed by an optical coherence tomography.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Label	Type	Description	Intervention Names
DXR stent group		Patients who undergo coronary intervention with DXR stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stent strut coverage (Incidence of uncovered strut)	Coronary angiography with OCT follow up	6 month

Secondary Outcomes

Measure	Description	Time Frame
Stent malapposition	Coronary angiography with OCT follow up	6 month
Stent thrombosis	Coronary angiography with OCT follow up	6 month

Other Outcomes

Measure	Description	Time Frame
major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)	Clinical outcome follow up	1 year
long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient
- Age >=19 years
- Clinically indicated to invasive coronary angiography
- Patient capable and willing of giving written informed consent
Angiographic
- coronary artery disease confined to native coronary artery
- >50% diameter stenosis by invasive coronary angiography
- reference diameter 2.5-4.0mm, lesion length ≤30 mm

Exclusion Criteria:

Patient
- Inability to provide written informed consent
- Serious comorbidity which may affect the trial by decision of investigators
- Prior CABG to target vessel
- Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30%
- Prior ST elevation myocardial infarction within 72 hours from the procedure
- Hemodynamic or electrical instability including shock
- Serious coronary artery spasm, unrelated to catheter
- Pregnancy or possible pregnant status
- Allergy to iodinated contrast agent
- Serum creatinine >=1.7 mg/dL or creatinine clearance <= 30 ml/min
- ST elevation myocardial infarction
Angiographic (OCT)
- Left main disease
- Severely calcified lesion
- Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who undergo coronary artery intervention with DXR stent

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Sang-Wook Kim, MD, PhD	Contact	+82-6299-1260		swivus@gmail.com

Name	Affiliation	Role
Sang-Wook Kim, MD, PhD	Chung-Ang University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Konyang University Hospital		Daejeon		35365	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases