A Prospective, Multicenter Study On the Effects of Progressive and Matched Caliber Balloon Predilation of Popliteal Artery On Treatment Strategy and Prognosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arteriosclerosis; Extremities
- Sponsor
- Jun-min Bao
- Enrollment
- 340
- Locations
- 11
- Primary Endpoint
- success rate of balloon repair
- Last Updated
- 6 years ago
Overview
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.
Investigators
Jun-min Bao
chairman of the expert committee of lower limb artery disease
Chinese Medical Association
Eligibility Criteria
Inclusion Criteria
- •Target lesions from superficial femoral artery to popliteal artery P1 segment; Proximal anatomical markers of target lesions:
- •1cm below the fork of the common femoral artery;
- •Distal anatomical sign of target lesions: upper border of patella;
- •Target lesions may be single, combined, or tandem primary lesions of stenosis and/or occlusion, and meet one of the following criteria:
- •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.
- •The total length of the lesion is less than 100mm.
- •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.
- •The diameter of the reference vessels of target lesions shall be 4mm or more and 7mm or less.
- •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:
Exclusion Criteria
- •The investigator believes that the subject has the possibility of non-compliance with the follow-up plan;
- •Patients with cerebral apoplexy or st-segment elevation myocardial infarction in the last 3 months;
- •Combined with the following diseases
- •Patients diagnosed with thrombotic occlusive vasculitis;
- •combined with abdominal aortic aneurysm/thoraco-abdominal aortic aneurysm (with mural thrombus inside the aneurysm cavity);
- •coagulation defect;
- •high coagulation status;
- •blood index
- •Serum creatinine \> 170umol;
- •White blood cell count \< 3.0 x 109/L or \> 14.0 x 109/L;
Outcomes
Primary Outcomes
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 Outcomes
- Balloon related adverse event rate(7 days after operation)