NCT04986098

Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons

Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons in the Treatment of Femoral Popliteal Artery Occlusion

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe \[8\], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. The combined application of DA and DCB in the treatment of peripheral arterial disease has a good early and mid-term effect. Konstantinos et al. reported that DARRT has a higher first-phase patency rate compared with DCB. A retrospective study by Sebastian et al. showed that compared with PTA after DA, the combination of DA and DCB has a better event-free survival rate after 12 months of follow-up. Therefore, DA combined with DCB therapy may be one of the best and most promising methods for the treatment of lower extremity ASO.

Conditions

• Peripheral Vascular Diseases

Interventions

Type	Name	Description
DEVICE	TurboHawk	Directly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel
DRUG	Paclitaxel	Paclitaxel

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-08-02
• Last updated: 2021-08-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study
• FDA-regulated device study