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

NCT ID: NCT02840786

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-08-31

Brief 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)

Detailed 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)

Conditions

Atherosclerosis; Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Stents

Stents group

Group Type: ACTIVE_COMPARATOR

balloon and Stent

Intervention Type: DEVICE

Intervention: Atherectomy

directional atherectomy group

Group Type: ACTIVE_COMPARATOR

plaque excision system

Intervention Type: DEVICE

Interventions

plaque excision system

Intervention Type: DEVICE

balloon and Stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gu Yong Quan

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

XuanwuH16

Identifier Type: -

Identifier Source: org_study_id