Multi-center Study On the Treatment and Prognosis of Arteriosclerosis Obliterans With Different Caliber Balloon
NCT ID: NCT03725683
Last Updated: 2019-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
340 participants
INTERVENTIONAL
2019-11-01
2020-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Incrementing groups
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;
Increased caliber balloon
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.
matching groups
Pre-dilatation of the matched caliber balloon, whose diameter = the target lesion's diameter as a reference vessel, was applied.
matched caliber balloon
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.
Interventions
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Increased caliber balloon
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 balloon
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.
Eligibility Criteria
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Inclusion Criteria
1. 1cm below the fork of the common femoral artery;
2. Distal anatomical sign of target lesions: upper border of patella;
2. Target lesions may be single, combined, or tandem primary lesions of stenosis and/or occlusion, and meet one of the following criteria:
1. 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.
2. The total length of the lesion is less than 100mm.
3. 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.
3. The diameter of the reference vessels of target lesions shall be 4mm or more and 7mm or less.
4. 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:
1. Residual stricture of the common iliac lesion \< 30%;
2. An upper knee has at least one or more free outflow tract, i.e., residual stenosis \< 50%;
3. No embolism, rupture or other serious adverse events occurred during the operation.
5. The pregnancy test results of fertile female subjects must be negative and there is no pregnancy plan during the study period;
6. The patient or client signs the patient's informed consent;
7. Understand and accept the duration of this study, and be able to cooperate with follow-up and evaluation;
8. Subject's life expectancy is greater than or equal to 12 months after evaluation by the investigator.
Exclusion Criteria
2. Patients with cerebral apoplexy or st-segment elevation myocardial infarction in the last 3 months;
3. Combined with the following diseases
1. Patients diagnosed with thrombotic occlusive vasculitis;
2. combined with abdominal aortic aneurysm/thoraco-abdominal aortic aneurysm (with mural thrombus inside the aneurysm cavity);
3. coagulation defect;
4. high coagulation status;
4. blood index
1. Serum creatinine \> 170umol;
2. White blood cell count \< 3.0 x 109/L or \> 14.0 x 109/L;
3. Patients with platelet count \< 80 x 109/L or \> 500 x 109/L;
5. Patients who are known to be allergic to anticoagulant, antiplatelet, contrast agent and other drugs; Examples: heparin, clopidogrel, iodixanol, etc.
6. Target lesions are non-primary lesions of restenosis and anastomotic stenosis within the stent;
7. Acute or subacute thrombosis of target lesions;
8. There are aneurysms in the vicinity of target lesions, and the proximity refers to no more than 20mm.
9. The patient is a lactating woman or a pregnant woman.
40 Years
85 Years
ALL
No
Sponsors
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Jun-min Bao
NETWORK
Responsible Party
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Jun-min Bao
chairman of the expert committee of lower limb artery disease
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Xuanwu Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Gulou Hospital
Nanjing, Jiangsu, China
Nanjing first hospital
Nanjing, Jiangsu, China
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanxi da Hospital
Taiyuan, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
People's Hospital of XinJiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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JUn-min Bao
Identifier Type: -
Identifier Source: org_study_id
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