AzTrials
AzTrials

Coronary Artery DiseaseNCT04767022

Compare the Safety and Effectiveness of Genoss® DCB and SeQuent® Please NEO in Chinese Patients with Coronary ISR

A study testing Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB) and Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO) in people with Coronary Artery Disease, run by Genoss Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB) and Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteChina
Study dates
30 Jan 2021to 30 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject related inclusion criteria
  • Age≥18 years old \& ≤80 years old.
  • Patients with stable angina pectoris, unstable angina pectoris, stable acute myocardial infarction or confirmed silent myocardial ischemia.
  • Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
  • It is suitable for patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
  • Desease related inclusion criteria
Show all 11Show fewer
  • The target lesions were in stent restenosis: Mehran type I, II and III stenosis.
  • The stenosis rate of target lesion diameter was more than 70%, or more than 50%, accompanied by objective evidence of ischemia (such as stress electrocardiogram, myocardial perfusion imaging, FFR, etc.)
  • The reference vessel diameter of the target lesion was 2.0-4.0 mm, and the target lesion length was less than or equal to 26 mm.
  • It is expected that no more than two drug balloons will be used in each subject, and each target lesion can be covered by one drug balloon.
  • At most 2 primary lesions need interventional treatment, and the distance from the target lesion is more than or equal to 10 mm, and can be successfully treated before the intervention of the target lesion.

Who cannot join

  • Subject related exclusion criteria
  • A woman who is pregnant, lactating, or planning a pregnancy.
  • Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or history of cerebral hemorrhage, subarachnoid hemorrhage, active peptic ulcer and gastrointestinal bleeding within 3 months before operation.
  • Patients who are known to be allergic to aspirin, clopidogrel, ticagrelor, heparin, contrast agent, paclitaxel, or have contraindications to aspirin, clopidogrel or ticagrelor.
  • Patients with acute myocardial infarction within 1 week before operation.
  • Patients with Takayasu arteritis.
Show all 21Show fewer
  • Left ventricular ejection fraction ≤ 30%.
  • Acute or chronic renal insufficiency (serum creatinine > 2.0mg/dl or 178 μ mol / L).
  • Patients with life expectancy less than 1 year.
  • Patients participating in clinical trials of other drugs or medical devices.
  • According to the researcher's judgment, the patient's clinical condition is not suitable for this study, or the patient is expected to be unable to complete the follow-up study according to the protocol.
  • Disease related exclusion criteria
  • The target lesion was total occlusion (Mehran type IV).
  • The target and non target lesions were left main artery lesions.
  • The target lesions were ostial, pontine and bifurcated lesions with branch diameter ≥ 2.5mm.
  • Three vessel disease requiring treatment.
  • More than 3 lesions (including target lesions and non target lesions) need to be treated in target vessels.
  • ISR lesions intervened within 6 months before operation.
  • Angiography confirmed thrombus in the target vessel.
  • The target vessel is severely calcified, tortuous and angulated, so it is expected that the drug balloon catheter will not pass successfully.
  • The lesions that could not be pre dilated successfully were grade C or above dissection after pre dilation, or residual stenosis > 30%, or TIMI blood flow < grade III.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Cardiology, First Affiliated Hospital of Air Force Medical University of Chinese PLA

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Trials to Evaluate the Safety and Effectiveness of Genoss® DCB Versus SeQuent® Please NEO in Patients with Coronary In-stent Restenosis (ISR)

The purpose of this study is to evaluate the safety and effectiveness of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO).

The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO.

In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.

Read the detailed description

In a randomized controlled trials to compare with the same-category medical device (Sequent® Please NEO), 224 patients with in-stent restenosis (ISR) were recruited from a total of 13 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group(Genoss® DCB) and the control group(SeQuent® Please NEO), and each of the test or control devices was assigned to receive the procedure.

All patients were followed up 30 days, 6 months, 9 months, 1 year and 2 years after procedure, and angiographic follow-up was performed 9 months after procedure.

Being tested
Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB), Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)
Keywords
In-Stent Restenosis
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB)Device

    Drug Coated Balloon

  • Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)Device

    Drug Coated Balloon

Study groups in NCT04767022
Study groupRoleWhat they receive
Genoss® DCBExperimentalPaclitaxel Coated PTCA Balloon Catheter
Receives: Device: Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB)
SeQuent® Please NEOActive comparatorPaclitaxel Coated PTCA Balloon Catheter
Receives: Device: Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-segment late lumen loss after procedure

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

    Measured: at 9 months after procedure

Secondary outcomes (4)

  1. Device-oriented compoiste endpoint (DOCE)

    DOCE is defined as a composite of cadiac death, target vessel-related myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR)

    Measured: at 30 days, 6 months, 9 months, 12 months and 24 months after procedure

  2. Patient-oriented composite endpoint (POCE)

    POCE is defined as a composite of all-cause death, any myocardial infarction, any revascularization

    Measured: at 30 days, 6 months, 9 months, 12 months, and 24 months after procedure

  3. Stent thrombosis by ARC definition

    Measured: at 6 months, 9 months, 12 months, 24 months after procedure

  4. Retenosis rate

    Measured: at 9 months after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start30 Jan 2021
  3. Primary completion20 Dec 2023
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04767022
Sponsor's protocol ID
CIP-DS1001-C
Status last verified
Feb 2025
First submitted
19 Feb 2021
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Paclitaxel Coated PTCA Balloon Catheter(Genoss® DCB) and Paclitaxel Coated PTCA Balloon Catheter(SeQuent® Please NEO) in people with Coronary Artery Disease, run by Genoss Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-segment late lumen loss after procedure (time frame: at 9 months after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04767022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in