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DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis — DELTA  

Femoral Artery Stenosis Clinical Trial

Official title:
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

Clinical Trial Summary

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

Clinical Trial Description

This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate achievement of optimal PTA dilatation. A total of 188 patients will be enrolled from 14 sites in China. All patients enrolled will be assigned to the test group (DKutting LL balloon, n=94) and the control group (Chocolate balloon, n=94) with randomized allocation ratio of 1:1. Primary endpoint is percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved. A 30-day after procedure follow-up will be conducted for all 188 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05608655
Study type Interventional
Source DK Medical Technology (Suzhou) Co., Ltd.
Contact
Status Completed
Phase N/A
Start date December 27, 2022
Completion date February 4, 2024
View Details
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