NCT05608655

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: DK Medical Technology (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Femoral Artery Stenosis
• Popliteal Artery Stenosis

Interventions

Type	Name	Description
DEVICE	DKutting LL balloon	After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
DEVICE	Chocolate balloon	After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment

Timeline

• Start date: 2022-12-27
• Primary completion: 2024-01-10
• Completion: 2024-02-04
• First posted: 2022-11-08
• Last updated: 2024-02-20

Locations

14 sites across 1 country: China