Femoropopliteal Artery OcclusionCIVILIANNCT05473884
Lesion Preparation in Femoropopliteal Artery Occlusion Disease
An observational study of Femoropopliteal Artery Occlusion and Atherosclerosis Obliterans, run by Shanghai Pudong Hospital at 1 site in China.
Trial summary
Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans, Lesion; Vascular
- What is being tested?
- lesion preparation devices and conventional balloon
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 May 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
General Inclusion Criteria:
- Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
- Patient has a score from 2 to 5 following Rutherford classification
- Unilateral or bilateral F-P occlusive lesions (enrollment of one or both target limbs depend on operators)
- Complete recanalization followed by POBA, Chocolate PTA, Scoring PTA, Shockwave PTA, SilverHawk, TurboHawk, Jetstream, Angiojet, Laser and Rotarex
Angiographic Inclusion Criteria:
- TASC II-Type A/B/C/D
- Iliac inflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)-less than 50% residual stenosis
- There is angiographic evidence of at least one-vessel-runoff (>10cm) to the foot
General Exclusion Criteria:
- Projected for major amputation of target limb (above ankle joint)
- Change to thrombectomy or bypass during operation
- Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated
- Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion
- female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
- Life expectancy of less than twelve months.
- Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
- Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days).
- Patient unwilling or unlikely to comply with Follow-Up schedule
Angiographic Exclusion Criteria:
- Testified for acute F-P arterial embolization
- Thromboangiitis obliterans
- Failed for recanalization
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201200
Bo Yu, M.D., +8618918922698, paul.yubo@gmail.com
Weihao Shi, M.D., 13601982603, vascular741021@163.com
About this study
Official title: CIVILIAN Study in Femoropopliteal Artery Occlusion Disease
Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.
Read the detailed description
Femoropopliteal artery occlusive disease is a common type of peripheral arterial disease (PAD). Hitherto, endovascular treatment has been testified and advocated as the first-line treatment of femoropopliteal occlusive disease. However, the in-stent restenosis has been a major limitation of well long-term patency rate in this segment due to physiological and geometrical issues. The concept "leave nothing behind" is proposed, and some vessel preparation methods and devices, such as directional atherectomy, rotational atherectomy, laser atherectomy are developed. This is a national, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions. A total of 1000 patients will be included in approximately 8 sites. The study is designed to demonstrate the inferiority of different vessel preparation strategies in various fields under long-term follow-up.
- Conditions
- Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans, Lesion; Vascular, In-stent Restenosis
- Being tested
- lesion preparation devices, conventional balloon
- Keywords
- femoropopliteal Artery Occlusion, debulking, drug-coated balloon, bail-out stenting, endovascular therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lesion preparation devicesDevice
Also called Chocolate balloon, Shockwave balloon, Rotarex, TurboHawk
successful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty
conventional balloonDevice
Lumen gain is achieved by plain old balloon angioplasty under working inflation pressure.
| Study group | Role | What they receive |
|---|---|---|
| lesion preparation with POBA in femoropopliteal Artery occlusion | Patients with femoropopliteal artery occlusion were treated by plain old balloon angioplasty followed with DCB. Receives: Device: conventional balloon | |
| lesion preparation with debulking devices in femoropopliteal Artery occlusion | Patients with femoropopliteal artery occlusion were treated by other lesion preparation devices, like Chocolate balloon, Shockwave balloon, TurboHawk, Jetstream and Rotarex and then followed by DCB. Receives: Device: lesion preparation devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from TLR
Percentage of participants with a 1-year TLR free survival
Measured: within 12 months post-procedure
Incidence of complications
Procedure-related complications at day 30, defined as: procedure-related distal embolization, acute post-procedural target vessel thrombosis, bleeding, perforation, acute renal failure
Measured: immediately following procedure (day 30)
Major adverse event
Major adverse events (MAE) rate at 1 year, defined as: Myocardial Infarction (MI), major amputation, all-cause mortality
Measured: within 12 months post-procedure
Secondary outcomes (7)
Technical Success
Technical success, defined as the ability to cross the target lesion with the device, set up antegrade blood flow and leave residual stenosis <30%
Measured: within 24 hours post-procedure
Incidence of dissection and types
Dissection patterns according to the National Heart, Lung and Blood Institute classification system for the coronary artery. (Type A-F) (A) Type A has minor radiolucent areas, (B) type B is a linear dissection, (C) type C has contrast outside the lumen, (D) type D is a spiral dissection, (E) type E has persistent filling defects, and (F) type F is a total occlusion without distal antegrade flow
Measured: immediately following vessel preparation
Incidence of Bailout stenting
Bailout stenting, defined as stent implantation after vessel preparation and DCB including bare metal stents (BMS), covered stents and drug-eluting stents (DES)
Measured: immediately following vessel preparation and DCB angioplasty
Amputation Free Survival
Percentage of participants with a 1-year amputation free survival
Measured: within 12 months post-procedure
Numbers of patients with Primary patency
Primary patency rate at 6, 12, 24 months as determined by Duplex ultrasound at six months, defined as a target vessel with <50% diameter stenosis (systolic velocity ratio no greater than 2.4), without occurrence of target lesion revascularization between the index procedure and follow-up control
Measured: within 3, 6, 12 months post-procedure
Improvement of ABI
Increase of Ankle-Brachial Index (ABI) at 12, 24 months, defined as: an increase in ABI compared to baseline
Measured: within 3, 6, 12 months post-procedure
Improvement of related symptoms
related symptoms could be identified as Rutherford classification from level 1-6.
improvement in Rutherford classification compared to the pre-procedure Rutherford classification
Measured: within 3, 6, 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jun 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Artery OcclusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Zhongshan Hospital, Huashan Hospital, First Affiliated Hospital of Zhejiang University, Xuanwu Hospital, Beijing, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Second Affiliated Hospital of Soochow University, Qingdao Hiser Medical Group
- Responsible party
- Principal investigator, Bo Yu, MD, Shanghai Pudong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473884
- Sponsor's protocol ID
- Shanghai-CIVILIAN
- Acronym
- CIVILIAN
- Status last verified
- Nov 2022
- First submitted
- 18 Jul 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIVILIAN Study in Femoropopliteal Artery Occlusion Disease
- ClinicalTrials.gov ID
- NCT05473884
- Acronym / sponsor ID
- CIVILIAN / Shanghai-CIVILIAN
- Conditions
- Femoropopliteal Artery Occlusion, Atherosclerosis Obliterans, Lesion; Vascular, In-stent Restenosis
- Keywords
- femoropopliteal Artery Occlusion, debulking, drug-coated balloon, bail-out stenting, endovascular therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Shanghai Zhongshan Hospital, Huashan Hospital, First Affiliated Hospital of Zhejiang University, Xuanwu Hospital, Beijing, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Second Affiliated Hospital of Soochow University, Qingdao Hiser Medical Group
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 26 Jul 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.
Peripheral arterial disease (PAD) carries a significant global health burden, and can limit functional capacity and quality of life. Percutaneous transluminal angioplasty (PTA) for PAD is often associated with suboptimal outcomes due to complications following balloon inflation related to vessel trauma and flow limiting dissections that may require bailout stenting. Different strategies and techniques to enhance both acute and longer-term outcomes with drug-coated balloons (DCB) are needed. This is a national, prospective, multi-center, non-randomized, real-world study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions.
Detailed description
Femoropopliteal artery occlusive disease is a common type of peripheral arterial disease (PAD). Hitherto, endovascular treatment has been testified and advocated as the first-line treatment of femoropopliteal occlusive disease. However, the in-stent restenosis has been a major limitation of well long-term patency rate in this segment due to physiological and geometrical issues. The concept "leave nothing behind" is proposed, and some vessel preparation methods and devices, such as directional atherectomy, rotational atherectomy, laser atherectomy are developed. This is a national, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of multiple vessel preparation strategies combined with drug-coating balloon (DCB) in Femoropopliteal Artery (F-PA) lesions. A total of 1000 patients will be included in approximately 8 sites. The study is designed to demonstrate the inferiority of different vessel preparation strategies in various fields under long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lesion preparation with POBA in femoropopliteal Artery occlusion | – | Device: conventional balloonPatients with femoropopliteal artery occlusion were treated by plain old balloon angioplasty followed with DCB. |
| lesion preparation with debulking devices in femoropopliteal Artery occlusion | – | Device: lesion preparation devicesPatients with femoropopliteal artery occlusion were treated by other lesion preparation devices, like Chocolate balloon, Shockwave balloon, TurboHawk, Jetstream and Rotarex and then followed by DCB. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No
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 |
|---|---|---|
| lesion preparation devicesAlso: Chocolate balloon, Shockwave balloon, Rotarex, TurboHawksuccessful recanalization of femoropopliteal artery occlusion and then followed by lesion preparation devices and plain old balloon angioplasty | Device | lesion preparation with debulking devices in femoropopliteal Artery occlusion |
| conventional balloonLumen gain is achieved by plain old balloon angioplasty under working inflation pressure. | Device | lesion preparation with POBA in femoropopliteal Artery occlusion |
Primary outcome
Freedom from TLR
Time frame: within 12 months post-procedure
Percentage of participants with a 1-year TLR free survival
Incidence of complications
Time frame: immediately following procedure (day 30)
Procedure-related complications at day 30, defined as: procedure-related distal embolization, acute post-procedural target vessel thrombosis, bleeding, perforation, acute renal failure
Major adverse event
Time frame: within 12 months post-procedure
Major adverse events (MAE) rate at 1 year, defined as: Myocardial Infarction (MI), major amputation, all-cause mortality
7 secondary outcomes
Technical Success
Time frame: within 24 hours post-procedure
Incidence of dissection and types
Time frame: immediately following vessel preparation
Incidence of Bailout stenting
Time frame: immediately following vessel preparation and DCB angioplasty
Amputation Free Survival
Time frame: within 12 months post-procedure
Numbers of patients with Primary patency
Time frame: within 3, 6, 12 months post-procedure
Improvement of ABI
Time frame: within 3, 6, 12 months post-procedure
Improvement of related symptoms
Time frame: within 3, 6, 12 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoropopliteal Artery Occlusion and Atherosclerosis Obliterans, run by Shanghai Pudong 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?
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 7 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Yu, M.D. (18918922698, paul.yubo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from TLR (time frame: within 12 months post-procedure). 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 7 Nov 2022.