NCT01903902

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.

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
1,000

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

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

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

2 years

First QC Date

July 17, 2013

Last Update Submit

July 18, 2013

Conditions

Coronary Artery Disease

Keywords

Coronary artery diseaseBalloon angioplastyDrug-eluting balloon

Outcome Measures

Primary Outcomes (2)

  • Late loss

    Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary

    9±1 months

  • Binary restenosis rate

    Restenosis rate of the target lesion at the follow-up quantitative coronary angiography

    9±1 months

Secondary Outcomes (2)

  • Neointimal hyperplasia

    9±1 months

  • Clinical outcomes

    9±1 months

Study Arms (1)

Drug-eluting balloon

EXPERIMENTAL

Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter \> 2.25 mm and ≤ 2.75 mm)

Device: SeQuent® Please Drug-eluting balloon

Interventions

SeQuent® Please Drug-eluting balloonDEVICE

Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length \< 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.

Drug-eluting balloon

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 19 years
  • Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length \< 25 mm)
  • Informed consent

You may not qualify if:

  • Chronic total obstruction lesion
  • Severe calcified lesion
  • Left main coronary lesion
  • Lesion having intravascular thrombus
  • Shock status from any cause including cardiogenic shock
  • Left ventricular ejection fraction \< 30%
  • Need for coronary artery bypass surgery
  • Allergic reaction for paclitaxel
  • Severe allergic for contrast agent (Visipaque) or statin
  • Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Woong Chul Kang, M.D.

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woong Chul Kang, M.D.

CONTACT

+82-32-460-3663kangwch@gilhospital.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 19, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 19, 2013

Record last verified: 2013-07

Locations

KR(1)