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

NCT04986098 | Unknown FDA Drug FDA Device

• 1 other identifier: Hongfei Sang
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary vascular patency rate

  Free-Target lesion reconstruction rate（F-TLR）at 24 months after operation

  24 months

• Major adverse event

  MAE within 24 months after surgery

  24 months

Secondary Outcomes (5)

• Quality of life assessment

  24 months

• ABI

  24 months

• Rutherford classification

  24 months

• TLR

  24 months

• TVR

  24 months

Interventions

TurboHawk DEVICE

Directly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel

Paclitaxel DRUG

Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ASO patients with femoral popliteal artery occlusion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

the Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 2, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

CN (1)