Angioplasty, BalloonNCT05175703
Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrainguinal Arteries
A study testing Passeo-18 Lux Paclitaxel releasing Balloon Catheter in people with Angioplasty, Balloon and Disease, Peripheral Artery, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The purpose of his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Angioplasty, Balloon, Disease, Peripheral Artery
- What is being tested?
- Passeo-18 Lux Paclitaxel releasing Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2018to 31 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person over 19 years old who is recognized as an adult in the civil law
- Person willing to sign a subject written consent
- Patient having infrainguinal arterial lesion that is adequate to intravascular treatment using Passeo-18 Lux Paclitaxel releasing Balloon Catheter
- Peripheral arterial disease in 2-5 grade of Rutherford
- Patient without at least one of significant lesions (≥50% of stenosis) in distal leaking artery. When there is at least one of opening blood vessels under the knee in treatment of arterial popliteal or at least one of opening cural vessel under the ankle in arterial treatment under the knee. Treatment of inflow arterial disease is allowed before the relevant treatment.)
Who cannot join
- Life expectancy ≤ 1 year
- Patient who is currently under medication of an investigation drug or treatment by a device that did not reach the primary endpoints.
- Subject during pregnancy or having a plan of pregnancy during the study period
- A guide wire could not passed into the target lesion (Successful passage of guide wire means its movement into the distal part of target lesion without causing arterial dissection or perforation by the end of guidewire.)
- Acute thrombosis is accompanied
- Major amputation is planned There is medical history of bypass surgery on target vessel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-centre, Sinlge Arm, Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries
The purpose of his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment.
Research institute for enrollment, and period; It is planned to enroll about 200 subjects in 9 domestic research institutes. It is expected to require about 12-18 months to enroll the subjects.
Subject follow-up schedule; Perform follow-up by phone call or clinical assessment at 1, 6, 12, and 24 months of the postoperative time point
Read the detailed description
This study is a prospective, multicenter, single arm, post-market registry subject to all the patient group with the relevant indications, where follow-up is performed in 1, 6, 12 (including angio follow up), and 24 month. The Passeo-18 Lux DCB including all the target patient group, is subject to every disease requiring revascularization in the infrainguinal arteries and is going to use the Passeo-18 Lux DCB.
The subject will receive percutaneous intervention using Passeo-18 Lux DCB according to the standard care guideline of this hospital. All complications and adverse events occurring during the operation will be recorded thoroughly. During the intervention, the number of lesions to be treated with Passeo-18 Lux will be determined carefully under judgment of the PI (When using more than one Passeo-18 Lux in a patient, maximum drug release recommended in the IFU should be considered.) The target lesion which is compose of one or several small lesions treatable with a balloon catheter is defined as a "treatment segment". The results of all the lesions treated with Passeo-18 Lux for the first time (regardless of which side limb) are going to be documented in eCRF, through which final results will be analyzed. All complications and adverse events from the intervention will be recorded thoroughly and reported to IRB according to the prescribed form.
Stent insertion into the lesion finishing treatment with drug coated balloon catheter will be determined by the study physician. For the subjects follow-up via phone call or clinical assessment will be conducted under below schedule. In this study the subjects who require stent insertion will not be classified as treatment failure. Before discharge of the subjects, medical prescription will follow the standard of care of this hospital, which will be documented. All the postoperative complications and adverse events will be recorded thoroughly and reported to IRB via suitable form. The subjects will be administered with proper anticoagulant, antiplatelet drug, and blood vessel dilator according to common and standard care guideline. The treatment follows the guideline described in IFU of Passeo-18 Lux DCB.
A subject does not have to participate in this study for treatment of the stenosed lower limb blood vessel. For example, there are a lot of devices available for treatment of the subject, including standard drug coated balloon, laser, and stent. The study physician will provide sufficient explanation on these alternative therapies for his/her understanding. Even though a subject decided not to participate in this study, it would not affect current and future treatment that he/she receives.
As the subjects of this study participate in in this study voluntarily according to their own will, they can discontinue the participation without any disadvantage or limitation at any time when they desire. They will not receive any disadvantage in later treatment from that. However the information collected during participation may be able to be used as it was anonymized. When a subject discontinued participation of study early, the participation should be terminated after completing preparation of eCRF as soon as possible. Also, The principal investigator regards a case as failure in follow-up of a subject up to for 24 months. In failing the follow-up, the principal investigator should record the failure of follow-up on the CRF.
- Conditions
- Angioplasty, Balloon, Disease, Peripheral Artery
- Being tested
- Passeo-18 Lux Paclitaxel releasing Balloon Catheter
- 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.
Passeo-18 Lux Paclitaxel releasing Balloon CatheterDevice
collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment.
| Study group | Role | What they receive |
|---|---|---|
| the infrainguinal arteries disease group | Other | Actual patient group with any atherosclerotic change in the infrainguinal arteries Receives: Device: Passeo-18 Lux Paclitaxel releasing Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical primary endpoints
No occurrence of Major Adverse Event (MAE); No death or lower limb amputation in the subject from the index procedure for 30 days
Measured: 30 days
Clinical primary endpoints
No occurrence of Major Adverse Event (MAE); No target vessel revascularization (TVR) within 6 months from index procedure.
Measured: 6 months
Functional primary endpoints
No target lesion revascularization (TLR) (a case showing at least 50% stenosis in visual inspection of target vessel in the patient with any recurred symptom) is needed clinically for 12 months after operation.
Measured: 12 months
Secondary outcomes (6)
TLR (Target Lesion Revascularzation) rate
ratio of TLR patients among full cohort within 6 ~ 24 months
Measured: 6-24 months
TVR rate
ratio of TVR patients among full cohort within 6 ~ 24 months
Measured: 6-24 months
Survival without amputation
Survival without amputation (survival without whole amputation including minor and major amputation) for 6, 12, and 24 months after operation
Measured: 6-24 months
device success
definition of device success : Successful guide, inflation, deflation, and withdrawal of the Passeo-18 Lux Paclitaxel releasing balloon catheter
Measured: during index procedure
Technical success
definition of technical success : Finished vascular procedure successfully and achieved ≤50% residual stenosis rate when assessing under visual inspection immediately after operation
Measured: during index procedure
Success in operation
definition of op : Defined it as the case that technical success and device success were achieved and no MAE occurred during the index procedure period.
Measured: during index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start5 Mar 2018
- Primary completion31 Aug 2021
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioplasty, BalloonStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The Passeo-18 Lux DCB
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Je Hwan Won, Ajou University School of Medicine
- Investigators
- Je Hwan Won, MD, Principal investigator, Korean Society of Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175703
- Sponsor's protocol ID
- AJIRB-DEV-DE4-17-478
- Status last verified
- Dec 2021
- First submitted
- 26 Oct 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Sinlge Arm, Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries
- ClinicalTrials.gov ID
- NCT05175703
- Acronym / sponsor ID
- AJIRB-DEV-DE4-17-478
- Conditions
- Angioplasty, Balloon, Disease, Peripheral Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 4 Jan 2022 (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 his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment.
Research institute for enrollment, and period; It is planned to enroll about 200 subjects in 9 domestic research institutes. It is expected to require about 12-18 months to enroll the subjects.
Subject follow-up schedule; Perform follow-up by phone call or clinical assessment at 1, 6, 12, and 24 months of the postoperative time point
Detailed description
This study is a prospective, multicenter, single arm, post-market registry subject to all the patient group with the relevant indications, where follow-up is performed in 1, 6, 12 (including angio follow up), and 24 month. The Passeo-18 Lux DCB including all the target patient group, is subject to every disease requiring revascularization in the infrainguinal arteries and is going to use the Passeo-18 Lux DCB.
The subject will receive percutaneous intervention using Passeo-18 Lux DCB according to the standard care guideline of this hospital. All complications and adverse events occurring during the operation will be recorded thoroughly. During the intervention, the number of lesions to be treated with Passeo-18 Lux will be determined carefully under judgment of the PI (When using more than one Passeo-18 Lux in a patient, maximum drug release recommended in the IFU should be considered.) The target lesion which is compose of one or several small lesions treatable with a balloon catheter is defined as a "treatment segment". The results of all the lesions treated with Passeo-18 Lux for the first time (regardless of which side limb) are going to be documented in eCRF, through which final results will be analyzed. All complications and adverse events from the intervention will be recorded thoroughly and reported to IRB according to the prescribed form.
Stent insertion into the lesion finishing treatment with drug coated balloon catheter will be determined by the study physician. For the subjects follow-up via phone call or clinical assessment will be conducted under below schedule. In this study the subjects who require stent insertion will not be classified as treatment failure. Before discharge of the subjects, medical prescription will follow the standard of care of this hospital, which will be documented. All the postoperative complications and adverse events will be recorded thoroughly and reported to IRB via suitable form. The subjects will be administered with proper anticoagulant, antiplatelet drug, and blood vessel dilator according to common and standard care guideline. The treatment follows the guideline described in IFU of Passeo-18 Lux DCB.
A subject does not have to participate in this study for treatment of the stenosed lower limb blood vessel. For example, there are a lot of devices available for treatment of the subject, including standard drug coated balloon, laser, and stent. The study physician will provide sufficient explanation on these alternative therapies for his/her understanding. Even though a subject decided not to participate in this study, it would not affect current and future treatment that he/she receives.
As the subjects of this study participate in in this study voluntarily according to their own will, they can discontinue the participation without any disadvantage or limitation at any time when they desire. They will not receive any disadvantage in later treatment from that. However the information collected during participation may be able to be used as it was anonymized. When a subject discontinued participation of study early, the participation should be terminated after completing preparation of eCRF as soon as possible. Also, The principal investigator regards a case as failure in follow-up of a subject up to for 24 months. In failing the follow-up, the principal investigator should record the failure of follow-up on the CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Passeo-18 Lux DCB
| Arm | Type | Receives |
|---|---|---|
| the infrainguinal arteries disease group | Other | Device: Passeo-18 Lux Paclitaxel releasing Balloon CatheterActual patient group with any atherosclerotic change in the infrainguinal arteries |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Person over 19 years old who is recognized as an adult in the civil law
- Person willing to sign a subject written consent
- Patient having infrainguinal arterial lesion that is adequate to intravascular treatment using Passeo-18 Lux Paclitaxel releasing Balloon Catheter
- Peripheral arterial disease in 2-5 grade of Rutherford
- Patient without at least one of significant lesions (≥50% of stenosis) in distal leaking artery. When there is at least one of opening blood vessels under the knee in treatment of arterial popliteal or at least one of opening cural vessel under the ankle in arterial treatment under the knee. Treatment of inflow arterial disease is allowed before the relevant treatment.)
Key exclusion criteria (6 listed)
- Life expectancy ≤ 1 year
- Patient who is currently under medication of an investigation drug or treatment by a device that did not reach the primary endpoints.
- Subject during pregnancy or having a plan of pregnancy during the study period
- A guide wire could not passed into the target lesion (Successful passage of guide wire means its movement into the distal part of target lesion without causing arterial dissection or perforation by the end of guidewire.)
- Acute thrombosis is accompanied
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 |
|---|---|---|
| Passeo-18 Lux Paclitaxel releasing Balloon Cathetercollect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment. | Device | the infrainguinal arteries disease group |
Primary outcome
Clinical primary endpoints
Time frame: 30 days
No occurrence of Major Adverse Event (MAE); No death or lower limb amputation in the subject from the index procedure for 30 days
Clinical primary endpoints
Time frame: 6 months
No occurrence of Major Adverse Event (MAE); No target vessel revascularization (TVR) within 6 months from index procedure.
Functional primary endpoints
Time frame: 12 months
No target lesion revascularization (TLR) (a case showing at least 50% stenosis in visual inspection of target vessel in the patient with any recurred symptom) is needed clinically for 12 months after operation.
6 secondary outcomes
TLR (Target Lesion Revascularzation) rate
Time frame: 6-24 months
TVR rate
Time frame: 6-24 months
Survival without amputation
Time frame: 6-24 months
device success
Time frame: during index procedure
Technical success
Time frame: during index procedure
Success in operation
Time frame: during index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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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
Korean Society of Interventional Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passeo-18 Lux Paclitaxel releasing Balloon Catheter in people with Angioplasty, Balloon and Disease, Peripheral Artery, run by Ajou University School of Medicine 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2022. 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?
Results are not available in the source record.
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?
Clinical primary endpoints (time frame: 30 days). The study lists 3 primary outcomes in all. 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 4 Jan 2022.