NCT02932995

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 12, 2016

Last Update Submit

October 18, 2016

Conditions

Coronary Artery DiseaseCoronary Stent Occlusion

Keywords

Optical Coherence TomographyDrug-Eluting Stent

Outcome Measures

Primary Outcomes (1)

  • Stent strut coverage (Incidence of uncovered strut)

    Coronary angiography with OCT follow up

    6 month

Secondary Outcomes (2)

  • Stent malapposition

    6 month

  • Stent thrombosis

    6 month

Other Outcomes (2)

  • major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)

    1 year

  • long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)

    3 year

Study Arms (1)

DXR stent group

Patients who undergo coronary intervention with DXR stent

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who undergo coronary artery intervention with DXR stent

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Konyang University Hospital

Daejeon, 35365, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

KyungHee University Medical Center

Seoul, 02447, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Ulsan university hospital

Ulsan, 44033, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Sang-Wook Kim, MD, PhD

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Wook Kim, MD, PhD

CONTACT

+82-6299-1260swivus@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2020

Last Updated

October 19, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(6)