Safety IssuesNCT05517291
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
A study testing paclitaxel-coated balloon angioplasty or bare mental stents implantation in people with Safety Issues and Efficacy, Self, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Safety Issues, Efficacy, Self
- What is being tested?
- paclitaxel-coated balloon angioplasty or bare mental stents implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age 18-85yrs.
- Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
- Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
- Rutherford category 2-5.
- Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
- The total length of target lesion ≤30cm.
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- Reference vessel diameter >4 mm and <6.5 mm by visual assessment.
- Patent inflow artery with stenosis <30% and at least 1 infrapopliteal artery to the ankle (<50% diameter stenosis).
- A guidewire has successfully traversed the target treatment segment.
Who cannot join
- Acute thrombus in the target vessels.
- Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
- Subject received prior stents implantation with in-stent restenosis or occlusion.
- Reintervention of the target lesion <90 days before the study procedure.
- Acquired thrombophilia or uncontrolled hypercoagulation states.
- Life expectancy <12 months.
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- Severe renal（SCr≥2.5 mg/dl）or hemodialysis dependence.
- Pregnancy, suspected pregnancy, or breastfeeding during study period.
- Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).
- Hypersensitivity to nitinol and/or paclitaxel.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Leng Ni, MD, 86-1069152501, nileng@163.com
About this study
Official title: Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial
This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.
- Conditions
- Safety Issues, Efficacy, Self
- Being tested
- paclitaxel-coated balloon angioplasty or bare mental stents implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-coated balloon angioplasty or bare mental stents implantationDevice
paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly
| Study group | Role | What they receive |
|---|---|---|
| DCB | Experimental | participants in this group will be received drug-coated balloon angioplasty Receives: Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation |
| stenting | Active comparator | participants in this group will be received primary selective stenting Receives: Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year primary patency rate
Measured: 1 year
Secondary outcomes (1)
clinical-driven target lesion revascularization
Measured: 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start18 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517291
- Sponsor's protocol ID
- PASS
- Status last verified
- Dec 2022
- First submitted
- 24 Aug 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05517291
- Acronym / sponsor ID
- PASS
- Conditions
- Safety Issues, Efficacy, Self
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 18 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Aug 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.
This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB | Experimental | Device: paclitaxel-coated balloon angioplasty or bare mental stents implantationparticipants in this group will be received drug-coated balloon angioplasty |
| stenting | Active comparator | Device: paclitaxel-coated balloon angioplasty or bare mental stents implantationparticipants in this group will be received primary selective stenting |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject age 18-85yrs.
- Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
- Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
- Rutherford category 2-5.
- Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
Key exclusion criteria (10 listed)
- Acute thrombus in the target vessels.
- Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
- Subject received prior stents implantation with in-stent restenosis or occlusion.
- Reintervention of the target lesion <90 days before the study procedure.
- Acquired thrombophilia or uncontrolled hypercoagulation states.
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 |
|---|---|---|
| paclitaxel-coated balloon angioplasty or bare mental stents implantationpaticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly | Device | DCB, stenting |
Primary outcome
1-year primary patency rate
Time frame: 1 year
1 secondary outcome
clinical-driven target lesion revascularization
Time frame: 1, 2 and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paclitaxel-coated balloon angioplasty or bare mental stents implantation in people with Safety Issues and Efficacy, Self, run by Peking Union Medical College Hospital 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 Dec 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leng Ni, MD (86-1069152501, nileng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year primary patency rate (time frame: 1 year). 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 6 Dec 2022.