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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Vascular Diseases
• Intervention / Treatment: Drug: Paclitaxel; Device: TurboHawk

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The Second Affiliated Hospital of Soochow University
      • Contact: Sang Hongfei, Doctorate; Phone Number: 0512-67784869 18606208970; Email: sanghongfei@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ASO patients with femoral popliteal artery occlusion

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	Quality of life assessment (VAS-QOL) after discharge, 1, 3, 6, 12, and 24 months after operation	24 months
ABI	Ankle-brachial index (ABI) at discharge, 1, 3, 6, 12, and 24 months after operation	24 months
Rutherford classification	Discharge, 1, 3, 6, 12, and 24 months after the Rutherford classification	24 months
TLR	The incidence of TLR after discharge, 1, 3, 6, 12, and 24 months	24 months
TVR	The incidence of TVR after discharge, 1, 3, 6, 12, and 24 months	24 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: Hongfei Sang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes