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

Peripheral Vascular Diseases Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986098
• Other study ID #: Hongfei Sang
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years old

• Ruthford grade 2-5 patients

• For patients whose arteries in both lower extremities meet the enrollment criteria, both lower extremities can be included

• At least one outflow tract over 10 cm at the distal end of the knee is continuous with a healthy back of the foot or internal and external arteries of the plantar

• The guide wire clearly passed through the lesion and the follow-up treatment was performed. In the case of failed anterograde passage, reverse puncture to achieve the guide wire through the lesion can also be included in the group

• After the failure of the first intracavitary treatment, the blood vessel can be recanalized by the intracavitary treatment again, and it can still be included in the group

• Patients with aortic iliac artery disease can be included in the group after the aortic artery is opened

• Patients who are willing to participate in this study and sign informed consent

• For severely infected R6 patients, if the infection is effectively controlled, they can be considered for inclusion

Exclusion Criteria:

• Patients who refuse to participate in this observational study

• Femoral popliteal artery disease with acute and subacute thrombosis

• Patients with thromboangiitis

• Patients who have failed endovascular treatment and transferred to surgical treatment

• For patients who have received plaque exfoliation on the femoral artery

• Patients who are allergic to heparin, low molecular weight heparin and contrast agents

• Patients enrolled in other clinical studies in the past 3 months

• Pregnant women

• Patients who have a life span of less than 2 years due to serious diseases

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• TurboHawk
Directly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel

Drug:
• Paclitaxel
Paclitaxel

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary vascular patency rate	Free-Target lesion reconstruction rate(F-TLR)at 24 months after operation	24 months
Primary	Major adverse event	MAE within 24 months after surgery	24 months
Secondary	Quality of life assessment	Quality of life assessment (VAS-QOL) after discharge, 1, 3, 6, 12, and 24 months after operation	24 months
Secondary	ABI	Ankle-brachial index (ABI) at discharge, 1, 3, 6, 12, and 24 months after operation	24 months
Secondary	Rutherford classification	Discharge, 1, 3, 6, 12, and 24 months after the Rutherford classification	24 months
Secondary	TLR	The incidence of TLR after discharge, 1, 3, 6, 12, and 24 months	24 months
Secondary	TVR	The incidence of TVR after discharge, 1, 3, 6, 12, and 24 months	24 months