NCT03189641

Brief Summary

The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

6 active sites

Status
completed

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

May 31, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2024

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

June 13, 2017

Last Update Submit

March 11, 2025

Conditions

Coronary Artery Disease

Keywords

Drug eluting stentsCoronary artery diseaseCoronary artery stenosisMyocardial ischemiaAngioplasty

Outcome Measures

Primary Outcomes (1)

  • In-segment late lumen loss as measured by quantitative coronary angiography (QCA)

    9 months

Secondary Outcomes (12)

  • Device Success rate

    Immediate post-procedure

  • Procedure success rate

    At the time of hospital discharge, expected 1or 2 days after of procedure

  • Target Lesion Failure (TLF)

    9 Months

  • Target Vessel Failure (TVF)

    9 Months

  • Stent thrombosis

    9 Months

  • +7 more secondary outcomes

Study Arms (1)

Cilostazol eluting stent system (CES-1)

EXPERIMENTAL
Device: Cilostazol eluting stent system (CES-1)

Interventions

Cilostazol eluting stent system (CES-1)DEVICE

Implantation of drug eluting stent

Cilostazol eluting stent system (CES-1)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<Clinical selection criteria\>
  • Patients who have provided written informed consent.
  • Patients who have evidence of myocardial ischemia confirmed by subjective symptoms (chest pain etc.), ST change in the electrocardiogram or objective findings.
  • Patients who are at least 20 years old.
  • \<Angiographic selection criteria\>
  • Single de novo lesion in native coronary arteries
  • Target vessel diameter is 2.75 mm to 3.25 mm.
  • TIMI flow is 2 or more.
  • Angiographic percent diameter stenosis (by visual estimation) is 75% or more in AHA classification

You may not qualify if:

  • Acute myocardial infarction Patients whose CK-MB or troponin exceeds the facility reference upper limit and have at least one of the following is confirmed are excluded as acute myocardial infarction.
  • Ischemic symptoms and Electrocardiographic findings showing continuous ischemia (eg, ST segment elevation or depression above 1 mm in contiguous leads, or the appearance of a new left bundle branch block).
  • Pathological Q waves on electrocardiogram
  • Myocardial necrotic focus or wall motion abnormality newly confirmed in diagnostic imaging
  • Patients who cannot be given emergency coronary artery bypass grafting (CABG).
  • Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.
  • Significant intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage etc. within the last 6 months
  • Surgical operation is planned that requires discontinuation of DAPT after the procedure
  • Anticoagulation therapy is underway and the risk of bleeding is high
  • Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.
  • Left ventricular ejection fraction (LVEF) is less than 30% within 30 days before the trial registration.
  • Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis).
  • Allergy to cobalt chrome alloy or contrast agent.
  • Patients who are participating in or will planning to participate in other clinical studies that may have clinical implications for the evaluation of this trial.
  • Patients who are pregnant or breast feeding.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tokai University Hospital

Isehara, Kanagawa, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Location

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, Japan

Location

Mitsui Memorial Hospital

Chiyoda City, Tokyo, Japan

Location

Teikyo University Hospital

tabashi City, Tokyo, Japan

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary StenosisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 16, 2017

Study Start

May 31, 2017

Primary Completion

March 27, 2020

Study Completion

July 26, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(6)