Peripheral Arterial DiseaseNCT06124755
The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions
A study testing Viabahn endoprosthesis group and Drug-coated balloon group in people with Peripheral Arterial Disease, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Viabahn endoprosthesis group and Drug-coated balloon group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient presented a score from 2 to 5 following Rutherford classification.
- The patient is willing to comply with specified follow-up evaluations at the specified times.
- The patient is ≥ 18 years old.
- Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
- The patient has a projected life expectancy of at least 24 months
- Before enrolment, the guidewire has crossed the target lesion
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- Subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (CTO) length ≥15cm.
- There is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot.
- Origin and proximal 1 cm of Superficial Femoral Artery (SFA) are patent.
- Reference vessel diameter (RVD) ≥ 4 mm by visual estimation.
Who cannot join
- Previous bypass surgery or stenting in the target vessel
- Patients who exhibit acute intraluminal thrombus at the target lesion vessel
- Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
- Pregnant women or Female patients with potential childbearing
- Use of thrombectomy, atherectomy, or laser devices during the procedure
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
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- The patient is currently participating in another investigational drug or device study that interferes with the study
- Significant renal dysfunction (Serum creatinine >3.0mg/dl)
- Patient with Known allergy to contrast media
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
- Femoral or popliteal aneurysm.
- Current peritoneal or hemodialysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions
The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.
Read the detailed description
This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Viabahn endoprosthesis group, Drug-coated balloon group
- Keywords
- Viabahn endoprosthesis, Drug-coated balloon
- 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.
Viabahn endoprosthesis groupDevice
Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.
Drug-coated balloon groupDevice
Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.
| Study group | Role | What they receive |
|---|---|---|
| Viabahn endoprosthesis group | Experimental | Femoropopliteal lesions treated with Viabahn endoprosthesis. Receives: Device: Viabahn endoprosthesis group |
| Drug-coated balloon group | Active comparator | Femoropopliteal lesions treated with drug-coated balloon endoprosthesis. Receives: Device: Drug-coated balloon group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Measured: 24-month
Freedom from a composite of Major adverse events (MAEs)
Freedom from MAEs is defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major amputation, and all-cause of death
Measured: 24-month
Secondary outcomes (7)
Procedural success
Procedural success is defined as technical or device success without major adverse events during the hospital stay.
Measured: Immediately after interventional surgery
Primary assisted patency
Primary assisted patency is defined as maintaining patency in the target vessel after a repeat intervention to regain patency prior to complete occlusion.
Measured: 24-month
Secondary patency
Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Measured: 24-month
Clinically-driven target vessel revascularization (CD-TVR)
clinically-driven target vessel revascularization (CD-TVR) is defined as repeat intervention performed during enrollment in the clinical study.
Measured: 24-month
Primary sustained clinical improvement
Defined as a sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.
Measured: 24-month
Secondary sustained clinical improvement
Defined as a sustained upward shift of at least one category on the Rutherford classification3, including the need for repeated target lesion revascularization (TLR) in surviving patients.
Measured: 24-month
Vasc quality of life score
Change of Vasc quality of life score
Measured: 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University, Xuanwu Hospital, Beijing, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Fudan University, Huashan Hospital, Xiamen Cardiovascular Hospital, Xiamen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124755
- Sponsor's protocol ID
- The Virtue study
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions
- ClinicalTrials.gov ID
- NCT06124755
- Acronym / sponsor ID
- The Virtue study
- Conditions
- Peripheral Arterial Disease
- Keywords
- Viabahn endoprosthesis, Drug-coated balloon
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University, Xuanwu Hospital, Beijing, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Fudan University, Huashan Hospital, Xiamen Cardiovascular Hospital, Xiamen University
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Nov 2023 (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 study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.
Detailed description
This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viabahn endoprosthesis group | Experimental | Device: Viabahn endoprosthesis groupFemoropopliteal lesions treated with Viabahn endoprosthesis. |
| Drug-coated balloon group | Active comparator | Device: Drug-coated balloon groupFemoropopliteal lesions treated with drug-coated balloon endoprosthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient presented a score from 2 to 5 following Rutherford classification.
- The patient is willing to comply with specified follow-up evaluations at the specified times.
- The patient is ≥ 18 years old.
- Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
- The patient has a projected life expectancy of at least 24 months
Key exclusion criteria (12 listed)
- Previous bypass surgery or stenting in the target vessel
- Patients who exhibit acute intraluminal thrombus at the target lesion vessel
- Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
- Pregnant women or Female patients with potential childbearing
- Use of thrombectomy, atherectomy, or laser devices during the procedure
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 |
|---|---|---|
| Viabahn endoprosthesis groupPatients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis. | Device | Viabahn endoprosthesis group |
| Drug-coated balloon groupPatients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon. | Device | Drug-coated balloon group |
Primary outcome
Primary patency
Time frame: 24-month
Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Freedom from a composite of Major adverse events (MAEs)
Time frame: 24-month
Freedom from MAEs is defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major amputation, and all-cause of death
7 secondary outcomes
Procedural success
Time frame: Immediately after interventional surgery
Primary assisted patency
Time frame: 24-month
Secondary patency
Time frame: 24-month
Clinically-driven target vessel revascularization (CD-TVR)
Time frame: 24-month
Primary sustained clinical improvement
Time frame: 24-month
Secondary sustained clinical improvement
Time frame: 24-month
Vasc quality of life score
Time frame: 24-month
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 9 Nov 2023.
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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 Viabahn endoprosthesis group and Drug-coated balloon group in people with Peripheral Arterial Disease, run by RenJi 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 10 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Nov 2023. 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 Qihong Ni, M.D. (+8615801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 24-month). The study lists 2 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 9 Nov 2023.