Clinical trial NCT03725683: Multi-center Study On the Treatment and Prognosis of Arteriosclerosis Obliterans With Different Caliber Balloon
Official title: A Prospective, Multicenter Study On the Effects of Progressive and Matched Caliber Balloon Predilation of Popliteal Artery On Treatment Strategy and Prognosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arteriosclerosis; Extremities
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2018-10-31
Enrollment: 340
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: success rate of balloon repair
timeFrame: during the surgery
Secondary outcomes:
measure: Balloon related adverse event rate
timeFrame: 7 days after operation
Other outcomes:
measure: 30days±7days related adverse event rate
timeFrame: 30days±7days
measure: 6months±30days related adverse event rate
timeFrame: 6months±30days
measure: 12months±30days related adverse event rate
timeFrame: 12months±30days
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Nanjing
country: China
facility: Gulou Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing first hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi da Hospital
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Urumqi
country: China
facility: People's Hospital of XinJiang Uygur Autonomous Region
state: Xinjiang
Study officials:
References: