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Multi-center Study On the Treatment and Prognosis of Arteriosclerosis Obliterans With Different Caliber Balloon

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ClinicalTrials.gov Identifier: NCT03725683
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jun-min Bao, Chinese Medical Association

Brief 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 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.

Condition or disease Intervention/treatment Phase
Arteriosclerosis; Extremities Device: Increased caliber balloon Device: matched caliber balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Study On the Effects of Progressive and Matched Caliber Balloon Predilation of Popliteal Artery On Treatment Strategy and Prognosis
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: 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;
Device: 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.


Experimental: matching groups
Pre-dilatation of the matched caliber balloon, whose diameter = the target lesion's diameter as a reference vessel, was applied.
Device: 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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Balloon related adverse event rate [ Time Frame: 7 days after operation ]

    Renal insufficiency due to surgery; Changes in coagulation function; Degree of arterial stenosis and Degree of limb ischemia;

    Other adverse events



Other Outcome Measures:
  1. 30days±7days related adverse event rate [ Time Frame: 30days±7days ]
    Changes in coagulation function; Degree of arterial stenosis and Degree of limb ischemia; Other adverse events

  2. 6months±30days related adverse event rate [ Time Frame: 6months±30days ]
    Changes in coagulation function; Degree of arterial stenosis and Degree of limb ischemia; Other adverse events

  3. 12months±30days related adverse event rate [ Time Frame: 12months±30days ]
    Changes in coagulation function; Degree of arterial stenosis and Degree of limb ischemia; Other adverse events



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Target lesions from superficial femoral artery to popliteal artery P1 segment; Proximal anatomical markers of target lesions:

    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.

    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.

  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:

  1. The investigator believes that the subject has the possibility of non-compliance with the follow-up plan;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725683


Contacts
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Contact: Junmin Bao, Doctor's degree 18801790869 ext 18801790869 bryantdj@163.com

Locations
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China, Anhui
Anhui Provincial Hospital Not yet recruiting
Hefei, Anhui, China, 230001
Contact    13956007036    xzlcyjhuhj@163.com   
Principal Investigator: Hejie Hu         
China, Beijing
Xuanwu Hospital Not yet recruiting
Beijing, Beijing, China, 100053
Contact    13671009746    xzlcyjguolr@163.com   
Principal Investigator: Lianrui Guo         
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 400016
Contact    13320201220    xzlcyjchengjuni@163.com   
Principal Investigator: Jun Cheng         
China, Jiangsu
Gulou Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210000
Contact       xzlcyjwangwei@163.com   
Principal Investigator: Wei Wang         
Nanjing first hospital Not yet recruiting
Nanjing, Jiangsu, China, 210001
Contact    18912954049    xzlcyjlwsh@163.com   
Principal Investigator: Wensheng Lou         
China, Shanghai
Shanghai Ninth People's Hospital Not yet recruiting
Shanghai, Shanghai, China, 20000
Contact    13801961446    xzlcyjymy@163.com   
Principal Investigator: Xintian Huang         
Shanghai Renji Hospital Not yet recruiting
Shanghai, Shanghai, China, 20000
Contact    13501611993    xzlcyjym@163.com   
Principal Investigator: Wei Liang         
Shanghai Zhongshan Hospital Not yet recruiting
Shanghai, Shanghai, China, 20000
Contact    13701913248    xzlcyjjjh@163.com   
Principal Investigator: Junhao Jiang         
China, Shanxi
Shanxi da Hospital Not yet recruiting
Taiyuan, Shanxi, China, 030000
Contact    13934566999    xzlcyjcaowd@163.com   
Principal Investigator: Wendong Cao         
China, Sichuan
The Affiliated Hospital of Southwest Medical University Not yet recruiting
Luzhou, Sichuan, China, 646000
Contact    13989131390    xzlcyjliuyong@163.com   
Principal Investigator: yong Liu         
China, Xinjiang
People's Hospital of XinJiang Uygur Autonomous Region Not yet recruiting
Urumqi, Xinjiang, China, 830001
Contact    13579218863    xzlcyjguansh@163.com   
Principal Investigator: Sheng Guan         
Sponsors and Collaborators
Jun-min Bao

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Responsible Party: Jun-min Bao, chairman of the expert committee of lower limb artery disease, Chinese Medical Association
ClinicalTrials.gov Identifier: NCT03725683     History of Changes
Other Study ID Numbers: JUn-min Bao
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arteriosclerosis
Arteriosclerosis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases