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

October 8, 2019 updated by: Jun-min Bao

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Junmin Bao, Doctor's degree
  • Phone Number: 18801790869 18801790869
  • Email: bryantdj@163.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Hejie Hu
    • Beijing
      • Beijing, Beijing, China, 100053
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • Jun Cheng
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
      • Nanjing, Jiangsu, China, 210001
        • Nanjing First Hospital
        • Contact:
        • Principal Investigator:
          • Wensheng Lou
    • Shanghai
      • Shanghai, Shanghai, China, 20000
        • Shanghai Ninth People's Hospital
        • Contact:
        • Principal Investigator:
          • Xintian Huang
      • Shanghai, Shanghai, China, 20000
        • Shanghai Renji Hospital
        • Contact:
      • Shanghai, Shanghai, China, 20000
        • Shanghai Zhongshan Hospital
        • Contact:
        • Principal Investigator:
          • Junhao Jiang
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Shanxi da Hospital
        • Contact:
        • Principal Investigator:
          • Wendong Cao
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • The Affiliated Hospital Of Southwest Medical University
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30days±7days
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
6months±30days
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
12months±30days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun-min Bao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (ACTUAL)

October 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JUn-min Bao

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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