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

Not Applicable

• Conditions: In-stent Arterial Restenosis; Atherosclerosis
• Interventions: Device: plaque excision system; Device: stent; Device: Balloon

• Registration Number: NCT02832024
• Lead Sponsor: Xuanwu Hospital, Beijing

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).

Study Timeline

• Study First Submitted: 2015-09-14
• Study Start: 2016-01
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Status Verified: 2019-05
• Primary Completion: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-04
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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: 1. Acute or subacute lower limb ischemia; 2. Severe calcification lesions; 3. Total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis>70%, or the distal runoff artery <1 root; 5. Previously lower extremity intervention or surgical graft artery bypass; 6. Severe renal insufficiency, creatinine level greater than 2.5 mg/dL; 7. The patient's platelet count is less than 100,000/uL, antiplatelet or anticoagulant contraindications to required medications; 8. Patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. Unwillingness to return for future follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Atherectomy	plaque excision system	Direct Atherectomy group
Intervention: Stents	stent	Stents group
Intervention: Balloon	Balloon	Balloon group

Primary Outcome Measures

Name	Time	Method
Primary Patency Rate	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.

Secondary Outcome Measures

Name	Time	Method
Technical success	1 day	Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.
Major Adverse Events	12 months	Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.
freedom from clinically-driven TLR	12 months	it is defined as freedom from clinically-driven target lesion revascularization
Limb Salvage Rate	12 months	Limb Salvage is defined as the freedom from secondary major amputation

Trial Locations

Locations (1)

Gu Yong Quan; 🇨🇳 Beijing, Beijing, China