Peripheral Arterial DiseaseNCT05868564
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
A study testing Atherectomy+Drug-coated balloon and Drug-coated balloon in people with Peripheral Arterial Disease, run by RenJi Hospital at 1 site in China.
Trial summary
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Atherectomy+Drug-coated balloon and Drug-coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Jul 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 must be between 18 and 85 years old;
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
- Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization;
- Patent distal popliteal artery and at least one patent distal runoff;
- Willing to comply with the follow-up evaluation;
- Written informed consent prior to any study procedures.
Who cannot join
- Women during pregnancy and lactation, or patients with baby planning;
- Life expectancy<2 years;
- Target lesion/vessel with in-stent restenosis
- Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months
- Subjects s who are currently participating in other interventional drug or device trials;
- Angiographic evidence of thrombus within the target vessel
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- Subjects have a history of stroke within 3 months;
- Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
- Concomitant Renal failure with a serum creatinine>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.
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: Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.
Read the detailed description
This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Atherectomy+Drug-coated balloon, Drug-coated balloon
- Keywords
- Atherectomy, 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.
Atherectomy+Drug-coated balloonDevice
Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group
Drug-coated balloonDevice
drug-coated balloon only in the active comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Atherectomy+Drug-coated balloon | Experimental | The lesion treated by atherectomy + UltrafreeTM drug-coated balloon. Receives: Device: Atherectomy+Drug-coated balloon |
| Drug-coated balloon | Active comparator | The lesion treated by UltrafreeTM drug-coated balloon only. Receives: Device: Drug-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Systolic Velocity Ratio (PSVR)
Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)
Measured: 12-month
Freedom from major adverse limb events（MALEs）
Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death
Measured: 12-month
Secondary outcomes (5)
Technical success
Defined as achievement of final residual diameter stenosis of <30% on the procedural completion angiogram, using the assigned device only, whereas lesion success is defined as achievement of <30% residual stenosis using any percutaneous method.
Measured: Immediately after endovascular treatment
Procedural success
Defined as technical or device success without the occurrence of major adverse events
Measured: During the hospital stay
Primary sustained clinical improvement
Defined as 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
Quality of life score
Quality of Life (QOL) score at 24 months; The minimum value is 1, and the maximum value is 7. The higher scores mean a better outcome.
Measured: 24-month
EuroQol five dimensions questionnaire (EQ 5D-5L) score
EQ 5D-5L score at 24 months；The minimum value is 0, and the maximum value is 5. The higher scores mean a worse outcome.
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 posted22 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, Affiliated Hospital of Nantong University, First Affiliated Hospital of Zhejiang University, Zhejiang University, Qingdao Hiser Medical Group, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital
- Responsible party
- Sponsor
- Investigators
- Meng Ye, M.D., Principal investigator, Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868564
- Sponsor's protocol ID
- The DEFINITIVE LL Study
- Status last verified
- May 2023
- First submitted
- 7 Mar 2023
- Last updated
- 22 May 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 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions
- ClinicalTrials.gov ID
- NCT05868564
- Acronym / sponsor ID
- The DEFINITIVE LL Study
- Conditions
- Peripheral Arterial Disease
- Keywords
- Atherectomy, drug coated balloon
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, Affiliated Hospital of Nantong University, First Affiliated Hospital of Zhejiang University, Zhejiang University, Qingdao Hiser Medical Group, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 May 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 study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.
Detailed description
This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atherectomy+Drug-coated balloon | Experimental | Device: Atherectomy+Drug-coated balloonThe lesion treated by atherectomy + UltrafreeTM drug-coated balloon. |
| Drug-coated balloon | Active comparator | Device: Drug-coated balloonThe lesion treated by UltrafreeTM drug-coated balloon only. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be between 18 and 85 years old;
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
- Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization;
- Patent distal popliteal artery and at least one patent distal runoff;
- Willing to comply with the follow-up evaluation;
Key exclusion criteria (9 listed)
- Women during pregnancy and lactation, or patients with baby planning;
- Life expectancy<2 years;
- Target lesion/vessel with in-stent restenosis
- Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months
- Subjects s who are currently participating in other interventional drug or device trials;
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 |
|---|---|---|
| Atherectomy+Drug-coated balloonPatients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group | Device | Atherectomy+Drug-coated balloon |
| Drug-coated balloondrug-coated balloon only in the active comparator group. | Device | Drug-coated balloon |
Primary outcome
Peak Systolic Velocity Ratio (PSVR)
Time frame: 12-month
Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)
Freedom from major adverse limb events（MALEs）
Time frame: 12-month
Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death
5 secondary outcomes
Technical success
Time frame: Immediately after endovascular treatment
Procedural success
Time frame: During the hospital stay
Primary sustained clinical improvement
Time frame: 24-month
Quality of life score
Time frame: 24-month
EuroQol five dimensions questionnaire (EQ 5D-5L) 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 22 May 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.
Meng Ye, M.D. principal investigator
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy+Drug-coated balloon and Drug-coated balloon 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 6 inclusion and 9 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 22 May 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 Ni Qihong, 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?
Peak Systolic Velocity Ratio (PSVR) (time frame: 12-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 22 May 2023.