Clinical Study of Stent Versus Direct Atherectomy to Treat Arteriosclerosis Occlusive Disease of Lower Extremity

Atherosclerosis Clinical Trial

Official title:

Occlusive Disease of Lower Extremity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840786
• Other study ID #: XuanwuH16
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2019

Study information

• Verified date: April 2016
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized study comparing stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Description:

This is a randomized study comparing balloon angioplasty adjunctive stent and plaque excision systems in treatment of Arteriosclerosis occlusive disease of lower extremity (superficial femoral or popliteal artery)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: August 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients were included if they were de novo stenosis>70% or occlusion of the femoropopliteal at least 18 years of age and referred for claudication (Rutherford-Becker class II-III) or critical limb ischemia (Rutherford-Becker class IV-V). 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

Related Conditions & MeSH terms

• Atherosclerosis
• Ischemia

Intervention

Device:
• plaque excision system

• balloon and Stent

Locations

Country	Name	City	State
China	Gu Yong Quan	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Beijing Chao Yang Hospital, Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-month Primary Patency Rate	systolic velocity ratio >2.4 as measured by Duplex ultrasound.	12 months
Secondary	Technical success	Technical success was defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.	1 day
Secondary	freedom from clinically-driven TLR	it is defined as thefreedom from clinically-driven target lesion revascularization	12 months
Secondary	Major Adverse Events at 12-month Post Procedure	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.	12 months
Secondary	12-month Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months