Aprospective, multicentre, single-arm clinical trial in which approximately 36 subjects would be enrolled using the Bridge 4.5 mm and 5.0 mm stent in accordance with the inclusion and exclusion criteria in this protocol. The success rate of immediate post-procedure stent target lesion treatment was recorded for all subjects, and the incidence of in-stent restenosis (≥50% stenosis) was assessed by DSA imaging follow-up at 6 months (±30 days) post-procedure. The subjects were also followed up at 30 days (±7 days), 6 months (±30 days), and 12 months (±60 days) after stent implantation to assess safety events during the follow-up period. .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Stent implantation
Beijing Tiantan Hospital Affilicated to Captical Medical University
Beijing, China
RECRUITINGIncidence of in-stent restenosis at 6 months postoperatively
Time frame: 180±30 days
Technical Success
DSA suggesting residual stenosis ≤20% after implantation
Time frame: post-implantation immediately
Any death or stroke during the follow-up associated with treatment in the target vessel supply region
Number of participants with death or stroke related to treatments for target vessel blood supply area
Time frame: 1 year after stent implantation
Any death or stroke
Number of participants with death or stroke
Time frame: 1 year after stent implantation
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