Clinical Trials Logo
  1. Home
  2. Femoral Artery Stenosis
  3. NCT05608655

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
See also
  Status Clinical Trial Phase
Completed NCT01947478 - MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery N/A
Not yet recruiting NCT04175197 - LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
Completed NCT01566461 - IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) N/A
Completed NCT01412541 - Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries N/A
Not yet recruiting NCT06410313 - First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease N/A
Recruiting NCT04709887 - Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot N/A
Completed NCT05617053 - DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS
Active, not recruiting NCT05734157 - CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery N/A
Withdrawn NCT04700371 - Vessel Deformations and Restenosis After Stenting of the Popliteal Artery N/A
Terminated NCT02813577 - Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM) N/A
Completed NCT03844724 - Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A