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

Not Applicable

• Conditions: Arteriosclerosis; Extremities
• Interventions: Device: Increased caliber balloon; Device: matched caliber balloon

• Registration Number: NCT03725683
• Lead Sponsor: Jun-min Bao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-09
• Study Start: 2019-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incrementing groups	Increased caliber balloon	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;
matching groups	matched caliber balloon	Pre-dilatation of the matched caliber balloon, whose diameter = the target lesion's diameter as a reference vessel, was applied.

Primary Outcome Measures

Name	Time	Method
success rate of balloon repair	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

Name	Time	Method
Balloon related adverse event rate	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

Trial Locations

Locations (11)

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Gulou Hospital; 🇨🇳 Nanjing, Jiangsu, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Nanjing first hospital; 🇨🇳 Nanjing, Jiangsu, China

People's Hospital of XinJiang Uygur Autonomous Region; 🇨🇳 Urumqi, Xinjiang, China

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China

Shanghai Renji Hospital; 🇨🇳 Shanghai, Shanghai, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The Affiliated Hospital of Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Shanxi da Hospital; 🇨🇳 Taiyuan, Shanxi, China