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

NCT02840786 | Completed DMC

• 1 other identifier: XuanwuH16
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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)

Conditions

Atherosclerosis; Ischemia

Keywords

stents; atherectomy; femoral artery; popliteal artery

Outcome Measures

Primary Outcomes (1)

• 12-month Primary Patency Rate

  systolic velocity ratio \>2.4 as measured by Duplex ultrasound.

  12 months

Secondary Outcomes (4)

• Technical success

  1 day

• freedom from clinically-driven TLR

  12 months

• Major Adverse Events at 12-month Post Procedure

  12 months

• 12-month Limb Salvage Rate

  12 months

Study Arms (2)

Intervention: Stents

ACTIVE COMPARATOR

Stents group

Device: balloon and Stent

Intervention: Atherectomy

ACTIVE COMPARATOR

directional atherectomy group

Device: plaque excision system

Interventions

plaque excision system DEVICE

Intervention: Atherectomy

balloon and Stent DEVICE

Intervention: Stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Beijing Friendship Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (1)

Gu Yong Quan

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Atherosclerosis; Ischemia

Interventions

Stents

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: December 4, 2019

Record last verified: 2016-04

Locations

CN (1)