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CompletedNCT04405063Updated May 17, 2024

Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patients With Coronary In-stent Restenosis

An interventional study of Paclitaxel Coated PTCA Balloon Catheter in Coronary Artery Disease, sponsored by Genoss Co., Ltd.. Completed. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by Genoss Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Nov 2016, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study 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)

Read the detailed description

In a randomized controlled trials to compare with the same-category medical device (Sequent® Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.

Drug release "stents" for PCI usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is different from the stent and the duration of follow up was set to 6 months.

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Conditions studied

  • Coronary Artery Disease

Keywords

  • In-Stent Restenosis
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In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 82 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Genoss Co., Ltd. is the lead sponsor of 18 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Genoss® DCB

    Paclitaxel Coated PTCA Balloon Catheter

    Device: Paclitaxel Coated PTCA Balloon Catheter

  • Active comparator
    SeQuent® Please

    Paclitaxel Coated PTCA Balloon Catheter

    Device: Paclitaxel Coated PTCA Balloon Catheter

Interventions

  • DevicePaclitaxel Coated PTCA Balloon Catheter

    Drug coated balloon

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What researchers measure

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

    Time frame: Follow-up angiography at 6 months after procedure

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 36339121 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04405063
Lead sponsor
Genoss Co., Ltd.
Responsible party
Sponsor
First posted
May 28, 2020
Start date
Nov 2016
Primary completion
Feb 2019
Completion
Feb 2019
Last update
May 17, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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