NCT04405063

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

May 17, 2024

Status Verified

October 1, 2021

Enrollment Period

2.3 years

First QC Date

May 18, 2020

Last Update Submit

May 16, 2024

Conditions

Coronary Artery Disease

Keywords

In-Stent Restenosis

Outcome Measures

Primary Outcomes (1)

  • In-segment late lumen loss after percutaneous coronary intervention in patients with ISR

    In-segment late lumen loss between test group(Genoss DCB) and control group(Sequent Please) evaluated by quantitiative coronary analysis in patients with ISR

    Follow-up angiography at 6 months after procedure

Study Arms (2)

Genoss® DCB

EXPERIMENTAL

Paclitaxel Coated PTCA Balloon Catheter

Device: Paclitaxel Coated PTCA Balloon Catheter

SeQuent® Please

ACTIVE COMPARATOR

Paclitaxel Coated PTCA Balloon Catheter

Device: Paclitaxel Coated PTCA Balloon Catheter

Interventions

Paclitaxel Coated PTCA Balloon CatheterDEVICE

Drug coated balloon

Genoss® DCBSeQuent® Please

Eligibility Criteria

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

You may qualify if:

  • Age ≥19 years old
  • Patients with significant coronary artery stenosis including left main coronary lesion (\> 50% diameter stenosis on coronary angiography)
  • Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
  • Patients suitable to receive coronary revascularization of any type
  • Restenosis Mehran type I-III after stent implantation for the first time
  • Patients with In-stent restenosis after 90 days of the stent implantation, and the degree of restenosis corresponds to Mehran type I-Ⅲ.
  • Diameter of the stent with restenosis should be 2.0-4.0mm (included). Length of the stenosis lesion should be no more than 40mm
  • In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form

You may not qualify if:

  • Patients with Infarct related artery (IRA) lesions among patients with acute myocardial infarction
  • Patients have restenosis lesions with thrombosis
  • Patients with a history of cardiogenic shock
  • Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
  • Patients with graft vessel lesion
  • Patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and paclitaxel
  • Patients with renal insufficiency (eGFR\<30mL/min)
  • Pregnant or lactating women
  • The patients have a life expectancy of less than 12 months
  • Patients who had reduced immunity or clinically significant abnormalities in the laboratory tests (hematological, serum biochemical, and urine tests) performed at the time of screening
  • Patients who had clinically significant disorders in cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or mental illness that significantly affects this study
  • Patients who are unsuitable for the study according to the investigator judges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jun EJ, Shin ES, Yuan SL, Bhak Y, Garg S, Kang WC, Kim JS, Kim JH, Bae JW, Rha SW, Chae IH. Comparison of 2 Different Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis: A Randomized Controlled Trial. JACC Asia. 2022 Mar 1;2(2):170-179. doi: 10.1016/j.jacasi.2021.11.015. eCollection 2022 Apr.

    PMID: 36339121DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 28, 2020

Study Start

November 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

May 17, 2024

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share