Peripheral Artery DiseaseNCT05134545
Compare the Effectiveness and Safety of Genoss® DCB and IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease
A study testing Genoss® DCB and IN.PACT Admiral® DCB in people with Peripheral Artery Disease and De Novo Stenosis, run by Genoss Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to demonstrate the non-inferiority of GENOSS DCB versus IN.PACT Admiral DCB on late lumen loss 6 months after the procedure in patients with de novo or non-stented restenotic lesions of the superficial femoral artery and popliteal artery and to evaluate the safety. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, De Novo Stenosis
- What is being tested?
- Genoss® DCB and IN.PACT Admiral® DCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2019to 30 Jun 2023
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 19 years and ≤ 85 years of age
- Documented ischemia with Rutherford classification 2, 3, 4 or 5
- Target lesion is in the SFA and/or PPA
- Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate
- Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion;
- 70% - 99% occluded with total lesion length ≥ 40 mm and ≤ 300 mm
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- 100% occluded with total lesion length ≤ 100 mm
- Combination lesions (a non-occlusive lesion that includes a totally occluded segment along its length) are eligible provided that (1) the combined lesion length is ≥ 40 mm and ≤ 300 mm and (2) the totally occluded segment is not greater than 100 mm in length.
- Tandem or adjacent lesions are treated as a single lesion, the gap between the lesions is ≤ 30 mm, and the total combined lesion length including the distance between the lesions is ≥ 40 mm and ≤ 300 mm
Who cannot join
- Stroke or STEMI within 3 months prior to enrollment
- Acute thrombosis or acute aneurysm in the target lesion
- History of or planning to have a major amputation in the leg
- Failure to successfully cross the target lesion with a guidewire
- Poor distal run-off artery to the ankle or lower
- Known allergies or sensitivities to paclitaxel, shellac, vitamin E, heparin, aspirin, other anticoagulant/antiplatelet therapies or contrast agent
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- Target lesion is one of the following;
- In-stent restenosis (ISR)
- Restenosis after DCB procedure
- Previously treated with bypass surgery
- Severe concentric calcified lesions on angiography where pre-dilation cannot be performed or failed, and the procedure for the device for clinical trials is inadequate
- Those who need stenting due to vascular dissection that restricts blood flow of Grade D or higher after pre-dilation
- Any major (e.g., cardiac, peripheral, abdominal) intervention (including in the contralateral SFA/PPA) planned within 30 days post index procedure
- Life expectancy, in the Investigator's opinion, is less than 12 months
- Chronic renal insufficiency with serum creatinine > 2.5 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Randomized, Double-blind, Pivotal Clinical Study to Evaluate the Effectiveness and Safety of GENOSS® DCB Versus IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease of Femoral and Popliteal Artery
The purpose of this clinical trial is to demonstrate the non-inferiority of GENOSS DCB versus IN.PACT Admiral DCB on late lumen loss 6 months after the procedure in patients with de novo or non-stented restenotic lesions of the superficial femoral artery and popliteal artery and to evaluate the safety.
This clinical trial will be conducted on a total of 118 patients at 11 domestic institutions (taking into account the dropout rate of 30%).
Read the detailed description
In this clinical trial, IN.PACT Admiral, which is the most similar to GENOSS DCB, a test device, and the product type and purpose of use, and whose effectiveness has already been proven through numerous clinical studies, was selected as a control product.
Due to the nature of this clinical trial, the investigator cannot be blinded to the treatment method to which the subject is assigned, so it is designed as a double-blind design in which only the subject and the independent evaluator are blinded.
For efficacy and safety evaluation, follow-up is performed up to 12 months after procedure of the clinical trial medical device.
The primary endpoint of the effectiveness evaluation was performed by an independent evaluator and CT angiography at 6 months of in-segment late lumen loss.
It is evaluated the revascularization rate, Rutherford classification, the amount of change in ABI or TBI at 1, 6, and 12 months, the procedural success rate during the clinical trial period, and the device success rate immediately after the procedure.
Safety evaluation is confirmed through all adverse events, MAE (Major adverse event), vital signs, physical examination and laboratory test results that occur to the subject during the clinical trial period after procedure of the clinical trial medical device.
- Conditions
- Peripheral Artery Disease, De Novo Stenosis
- Being tested
- Genoss® DCB, IN.PACT Admiral® DCB
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genoss® DCBDevice
Peripheral Drug Coated Balloon
IN.PACT Admiral® DCBDevice
Peripheral Drug Coated Balloon
| Study group | Role | What they receive |
|---|---|---|
| Genoss® DCB | Experimental | Paclitaxel Coated PTA Balloon Catheter Receives: Device: Genoss® DCB |
| IN.PACT Admiral® DCB | Active comparator | Paclitaxel Coated PTA Balloon Catheter Receives: Device: IN.PACT Admiral® DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery
late lumen loss between test group and control group evaluated by CT angiography in patients with peripheral artery disease of femoral and popliteal artery
Measured: Follow-up CT angiography at 6 months after the procedure
Secondary outcomes (6)
Target lesion revascularization
Proportion of subjects who underwent revascularization because the ABI (or TBI) decreased by 20% or more, or exceeded 0.15, or showed clinically significant ischemic symptoms compared to immediately after the procedure
Measured: at 1 months, 6 months, and 12 months after procedure
Change in ABI or TBI
The amount of ABI(Ankle-brachial index) or TBI(Toe-brachial index) change after the procedure compared to before the procedure is evaluated between the test group and the control group.
Measured: at 1 month, 6 months, and 12 months after procedure
Changes in Rutherford classification
The amount of change in Rutherford classification after the procedure compared to before the procedure is evaluated between the test group and the control group.
Measured: at 1 month, 6 months, and 12 months after procedure
Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery
Restenosis is defined as a case where the DS(Diameter stenosis) of the reference vessel diameter is 50% or more when the successfully treated lesion is evaluated through CT angiography.
Measured: Follow-up CT angiography at 6 months after procedure
Device success rate, %
It is defined as a device that has successfully reached the target lesion during the procedure, undergoes normal balloon inflation and deflation, and is fully recovered without balloon rupture.
Measured: immediately after the procedure
Procedural success rate, %
During the clinical trial period, no postoperative death, target vessel revascularization (TVR), lower extremity amputation, or target lesion thrombosis is defined as procedural success.
Measured: at 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start24 Mar 2019
- Primary completion30 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Genoss Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Je Hwan Won, MD, Principal investigator, Department of Radiology, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134545
- Sponsor's protocol ID
- CSP-DS1411
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Double-blind, Pivotal Clinical Study to Evaluate the Effectiveness and Safety of GENOSS® DCB Versus IN.PACT Admiral® DCB in Patients With Peripheral Artery Disease of Femoral and Popliteal Artery
- ClinicalTrials.gov ID
- NCT05134545
- Acronym / sponsor ID
- CSP-DS1411
- Conditions
- Peripheral Artery Disease, De Novo Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to demonstrate the non-inferiority of GENOSS DCB versus IN.PACT Admiral DCB on late lumen loss 6 months after the procedure in patients with de novo or non-stented restenotic lesions of the superficial femoral artery and popliteal artery and to evaluate the safety.
This clinical trial will be conducted on a total of 118 patients at 11 domestic institutions (taking into account the dropout rate of 30%).
Detailed description
In this clinical trial, IN.PACT Admiral, which is the most similar to GENOSS DCB, a test device, and the product type and purpose of use, and whose effectiveness has already been proven through numerous clinical studies, was selected as a control product.
Due to the nature of this clinical trial, the investigator cannot be blinded to the treatment method to which the subject is assigned, so it is designed as a double-blind design in which only the subject and the independent evaluator are blinded.
For efficacy and safety evaluation, follow-up is performed up to 12 months after procedure of the clinical trial medical device.
The primary endpoint of the effectiveness evaluation was performed by an independent evaluator and CT angiography at 6 months of in-segment late lumen loss.
It is evaluated the revascularization rate, Rutherford classification, the amount of change in ABI or TBI at 1, 6, and 12 months, the procedural success rate during the clinical trial period, and the device success rate immediately after the procedure.
Safety evaluation is confirmed through all adverse events, MAE (Major adverse event), vital signs, physical examination and laboratory test results that occur to the subject during the clinical trial period after procedure of the clinical trial medical device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genoss® DCB | Experimental | Device: Genoss® DCBPaclitaxel Coated PTA Balloon Catheter |
| IN.PACT Admiral® DCB | Active comparator | Device: IN.PACT Admiral® DCBPaclitaxel Coated PTA Balloon Catheter |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 19 years and ≤ 85 years of age
- Documented ischemia with Rutherford classification 2, 3, 4 or 5
- Target lesion is in the SFA and/or PPA
- Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate
- Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion;
Key exclusion criteria (15 listed)
- Stroke or STEMI within 3 months prior to enrollment
- Acute thrombosis or acute aneurysm in the target lesion
- History of or planning to have a major amputation in the leg
- Failure to successfully cross the target lesion with a guidewire
- Poor distal run-off artery to the ankle or lower
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genoss® DCBPeripheral Drug Coated Balloon | Device | Genoss® DCB |
| IN.PACT Admiral® DCBPeripheral Drug Coated Balloon | Device | IN.PACT Admiral® DCB |
Primary outcome
late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery
Time frame: Follow-up CT angiography at 6 months after the procedure
late lumen loss between test group and control group evaluated by CT angiography in patients with peripheral artery disease of femoral and popliteal artery
6 secondary outcomes
Target lesion revascularization
Time frame: at 1 months, 6 months, and 12 months after procedure
Change in ABI or TBI
Time frame: at 1 month, 6 months, and 12 months after procedure
Changes in Rutherford classification
Time frame: at 1 month, 6 months, and 12 months after procedure
Restenosis rate after procedure in patients with peripheral artery disease of femoral and popliteal artery
Time frame: Follow-up CT angiography at 6 months after procedure
Device success rate, %
Time frame: immediately after the procedure
Procedural success rate, %
Time frame: at 12 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Je Hwan Won, MD principal investigator
Department of Radiology, Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genoss® DCB and IN.PACT Admiral® DCB in people with Peripheral Artery Disease and De Novo Stenosis, run by Genoss Co., Ltd. at 1 site in South Korea.
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 9 inclusion and 15 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 23 Aug 2024. 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 South Korea. 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?
late lumen loss after procedure in patients with peripheral artery disease of femoral and popliteal artery (time frame: Follow-up CT angiography at 6 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2024.