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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04986098
Other study ID # Hongfei Sang
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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