DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02932995
• Other study ID #: C2015201
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 12, 2016
• Last updated: October 18, 2016
• Start date: October 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2016
• Source: Chung-Ang University
• Contact: Sang-Wook Kim, MD, PhD
• Phone: +82-6299-1260
• Email: swivus[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patient

• Age >=19 years

• Clinically indicated to invasive coronary angiography

• Patient capable and willing of giving written informed consent

2. 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:

1. 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

2. 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stent Occlusion
• Myocardial Ischemia
• Thrombosis

Locations

Country	Name	City	State
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Ulsan university hospital	Ulsan

Sponsors (6)

Lead Sponsor	Collaborator
Chung-Ang University	Jeju National University Hospital, Konyang University Hospital, Korea University Guro Hospital, Kyunghee University Medical Center, Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)	Clinical outcome follow up	1 year	No
Other	long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)	Clinical outcome follow up	3 year	No
Primary	Stent strut coverage (Incidence of uncovered strut)	Coronary angiography with OCT follow up	6 month	No
Secondary	Stent malapposition	Coronary angiography with OCT follow up	6 month	No
Secondary	Stent thrombosis	Coronary angiography with OCT follow up	6 month	No