Clinical Study of Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis

Xuanwu Hospital, Beijing1 site in 1 country120 target enrollmentJanuary 2016

ConditionsAtherosclerosis In-stent Arterial Restenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atherosclerosis
Sponsor: Xuanwu Hospital, Beijing
Enrollment: 120
Locations: 1
Primary Endpoint: Primary Patency Rate
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).

Detailed Description

This is a randomized study comparing Stent Versus Direct Atherectomy Versus Angioplasty to Treat Lower Limb In-stent Restenosis (superficial femoral or popliteal artery).

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

December 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xuanwu Hospital, Beijing

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial In-stent restenosis Disease located within the femoropopliteal artery Patient has a In-stent restenosis lesion(s) with \>50% stenosis documented angiographically Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.

Exclusion Criteria

•They were excluded if they had one or more of the following:
•Acute or subacute lower limb ischemia;
•Severe calcification lesions;
•Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization
•untreated ipsilateral iliac artery stenosis\>70%, or the distal runoff artery \<1 root;
•Previously lower extremity intervention or surgical graft artery bypass;
•Severe renal insufficiency, creatinine level greater than 2.5 mg/dL;
•The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications;
•Patients with immune system diseases or malignant tumours;
•ongoing active infection

Outcomes

Primary Outcomes

Primary Patency Rate

Time Frame: 12 months

Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \>50% with a peak systolic velocity ratio \>2.4 as measured by Duplex ultrasound.