Arteriosclerosis; ExtremitiesNCT03725683
Multi-center Study On the Treatment and Prognosis of Arteriosclerosis Obliterans With Different Caliber Balloon
A study testing Increased caliber balloon and matched caliber balloon in people with Arteriosclerosis; Extremities, run by Jun-min Bao at 11 sites in China.
Trial summary
In the endoscopic treatment of superficial femoral artery and/or proximal popliteal artery in patients with lower extremity arteriosclerosis occlusion, the intercalation caused by the predilation of increasing caliber balloon and matching caliber balloon was compared, and then the impact of the two predilation methods… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Arteriosclerosis; Extremities
- What is being tested?
- Increased caliber balloon and matched caliber balloon
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 11 sitesChina
- Study dates
- 1 Nov 2019to 1 Nov 2020
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Target lesions from superficial femoral artery to popliteal artery P1 segment; Proximal anatomical markers of target lesions:
- 1cm below the fork of the common femoral artery;
- Distal anatomical sign of target lesions: upper border of patella;
- Target lesions may be single, combined, or tandem primary lesions of stenosis and/or occlusion, and meet one of the following criteria:
- In contrast, The stenosis rate was greater than or equal to 70% and less than 100%, and the total length of the lesions was greater than or equal to 40mm and less than or equal to 200mm.
- The total length of the lesion is less than 100mm.
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- The total length of the lesion is less than or equal to 200mm, and the length of the occlusion segment is less than or equal to 100mm.
- Note: the distance between the lesions is no more than 30mm, and the distance between the lesions is > 30mm. Patients with multiple target lesions judged as 2 or more independent lesions met the inclusion criteria.
- The diameter of the reference vessels of target lesions shall be 4mm or more and 7mm or less.
- If the subject has ipsilateral iliac or lower knee lesions to be treated, the above lesions shall be successfully treated with target lesions, and the following criteria shall be met:
- Residual stricture of the common iliac lesion < 30%;
- An upper knee has at least one or more free outflow tract, i.e., residual stenosis < 50%;
- No embolism, rupture or other serious adverse events occurred during the operation.
- The pregnancy test results of fertile female subjects must be negative and there is no pregnancy plan during the study period;
- The patient or client signs the patient's informed consent;
- Understand and accept the duration of this study, and be able to cooperate with follow-up and evaluation;
- Subject's life expectancy is greater than or equal to 12 months after evaluation by the investigator.
Who cannot join
- The investigator believes that the subject has the possibility of non-compliance with the follow-up plan;
- Patients with cerebral apoplexy or st-segment elevation myocardial infarction in the last 3 months;
- Combined with the following diseases
- Patients diagnosed with thrombotic occlusive vasculitis;
- combined with abdominal aortic aneurysm/thoraco-abdominal aortic aneurysm (with mural thrombus inside the aneurysm cavity);
- coagulation defect;
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- high coagulation status;
- blood index
- Serum creatinine > 170umol;
- White blood cell count < 3.0 x 109/L or > 14.0 x 109/L;
- Patients with platelet count < 80 x 109/L or > 500 x 109/L;
- Patients who are known to be allergic to anticoagulant, antiplatelet, contrast agent and other drugs; Examples: heparin, clopidogrel, iodixanol, etc.
- Target lesions are non-primary lesions of restenosis and anastomotic stenosis within the stent;
- Acute or subacute thrombosis of target lesions;
- There are aneurysms in the vicinity of target lesions, and the proximity refers to no more than 20mm.
- The patient is a lactating woman or a pregnant woman.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
13671009746, xzlcyjguolr@163.com
Lianrui Guo
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
13320201220, xzlcyjchengjuni@163.com
Jun Cheng
Anhui Provincial Hospital
Hefei, Anhui, 230001
13956007036, xzlcyjhuhj@163.com
Hejie Hu
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
13989131390, xzlcyjliuyong@163.com
yong Liu
Gulou Hospital
Nanjing, Jiangsu, 210000
xzlcyjwangwei@163.com
Wei Wang
Nanjing first hospital
Nanjing, Jiangsu, 210001
18912954049, xzlcyjlwsh@163.com
Wensheng Lou
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 20000
13801961446, xzlcyjymy@163.com
Xintian Huang
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 20000
13501611993, xzlcyjym@163.com
Wei Liang
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 20000
13701913248, xzlcyjjjh@163.com
Junhao Jiang
Shanxi da Hospital
Taiyuan, Shanxi, 030000
13934566999, xzlcyjcaowd@163.com
Wendong Cao
People's Hospital of XinJiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
13579218863, xzlcyjguansh@163.com
Sheng Guan
About this study
Official title: A Prospective, Multicenter Study On the Effects of Progressive and Matched Caliber Balloon Predilation of Popliteal Artery On Treatment Strategy and Prognosis
In the endoscopic treatment of superficial femoral artery and/or proximal popliteal artery in patients with lower extremity arteriosclerosis occlusion, the intercalation caused by the predilation of increasing caliber balloon and matching caliber balloon was compared, and then the impact of the two predilation methods on the intraoperative treatment strategy and short and medium-term prognosis was analyzed. The study was designed as a prospective, multi-center, single-blind, randomized, controlled study. It is planned to set up 5-10 research centers with 340 subjects, and the single center will be less than or equal to 100 subjects, in the form of competition from each research center.
- Conditions
- Arteriosclerosis; Extremities
- Being tested
- Increased caliber balloon, matched caliber balloon
- Medical subject headings
- Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased caliber balloonDevice
Imaging of target lesions was performed before surgery to evaluate the characteristics of target lesions.
Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI(ankle-brachial pressure index);Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events.
matched caliber balloonDevice
Imaging of target lesions was performed before surgery to evaluate the characteristics of target lesions.
Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI index;Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Incrementing groups | Experimental | Each of the Increased caliber balloon capsules was predilated one by one, and the order of the increased balloon capsules was as follows: Balloon 2 diameter = target lesion reference vessel diameter minus 1; Balloon 3 diameter = target lesion reference vessel diameter; Receives: Device: Increased caliber balloon |
| matching groups | Experimental | Pre-dilatation of the matched caliber balloon, whose diameter = the target lesion's diameter as a reference vessel, was applied. Receives: Device: matched caliber balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of balloon repair
During the surgery:successful conduction, accurate positioning and release, and no narrowing or blocking of the balloon. Immediately after the balloon release, angiography shows balloon patency, successful expansion of stenosis, and arteriorrhexis or dissection rupture.
Measured: during the surgery
Secondary outcomes (1)
Balloon related adverse event rate
Renal insufficiency due to surgery; Changes in coagulation function; Degree of arterial stenosis and Degree of limb ischemia；
Other adverse events
Measured: 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriosclerosis; ExtremitiesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun-min Bao
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Jun-min Bao, Chinese Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725683
- Sponsor's protocol ID
- JUn-min Bao
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2018
- Last updated
- 9 Oct 2019
- Results posted
- 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 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study On the Effects of Progressive and Matched Caliber Balloon Predilation of Popliteal Artery On Treatment Strategy and Prognosis
- ClinicalTrials.gov ID
- NCT03725683
- Acronym / sponsor ID
- JUn-min Bao
- Conditions
- Arteriosclerosis; Extremities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Jun-min BaoResearch network
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 31 Oct 2018 (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.
In the endoscopic treatment of superficial femoral artery and/or proximal popliteal artery in patients with lower extremity arteriosclerosis occlusion, the intercalation caused by the predilation of increasing caliber balloon and matching caliber balloon was compared, and then the impact of the two predilation methods on the intraoperative treatment strategy and short and medium-term prognosis was analyzed. The study was designed as a prospective, multi-center, single-blind, randomized, controlled study. It is planned to set up 5-10 research centers with 340 subjects, and the single center will be less than or equal to 100 subjects, in the form of competition from each research center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incrementing groups | Experimental | Device: Increased caliber balloonEach of the Increased caliber balloon capsules was predilated one by one, and the order of the increased balloon capsules was as follows: Balloon 2 diameter = target lesion reference vessel diameter minus 1; Balloon 3 diameter = target lesion reference vessel diameter; |
| matching groups | Experimental | Device: matched caliber balloonPre-dilatation of the matched caliber balloon, whose diameter = the target lesion's diameter as a reference vessel, was applied. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Target lesions from superficial femoral artery to popliteal artery P1 segment; Proximal anatomical markers of target lesions:
- Target lesions may be single, combined, or tandem primary lesions of stenosis and/or occlusion, and meet one of the following criteria:
- Note: the distance between the lesions is no more than 30mm, and the distance between the lesions is > 30mm. Patients with multiple target lesions judged as 2 or more independent lesions met the inclusion criteria.
- The diameter of the reference vessels of target lesions shall be 4mm or more and 7mm or less.
- If the subject has ipsilateral iliac or lower knee lesions to be treated, the above lesions shall be successfully treated with target lesions, and the following criteria shall be met:
Key exclusion criteria (16 listed)
- The investigator believes that the subject has the possibility of non-compliance with the follow-up plan;
- Patients with cerebral apoplexy or st-segment elevation myocardial infarction in the last 3 months;
- Combined with the following diseases
- blood index
- Patients who are known to be allergic to anticoagulant, antiplatelet, contrast agent and other drugs; Examples: heparin, clopidogrel, iodixanol, etc.
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 |
|---|---|---|
| Increased caliber balloonImaging of target lesions was performed before surgery to evaluate the characteristics of target lesions. Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI(ankle-brachial pressure index);Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events. | Device | Incrementing groups |
| matched caliber balloonImaging of target lesions was performed before surgery to evaluate the characteristics of target lesions. Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI index;Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events. | Device | matching groups |
Primary outcome
success rate of balloon repair
Time frame: during the surgery
During the surgery:successful conduction, accurate positioning and release, and no narrowing or blocking of the balloon. Immediately after the balloon release, angiography shows balloon patency, successful expansion of stenosis, and arteriorrhexis or dissection rupture.
1 secondary outcome
Balloon related adverse event rate
Time frame: 7 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- 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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased caliber balloon and matched caliber balloon in people with Arteriosclerosis; Extremities, run by Jun-min Bao at 11 sites 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 17 inclusion and 16 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 Junmin Bao, Doctor's degree (18801790869 ext. 18801790869, bryantdj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of balloon repair (time frame: during the surgery). 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 Oct 2019.