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

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 Overview

• Status: Unknown
• Conditions: Atherosclerosis; In-stent Arterial Restenosis
• Intervention / Treatment: Device: plaque excision system; Device: Balloon; Device: stent

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Gu Yong Quan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention: Stents; Stents group	Device: stent
Active Comparator: Intervention: Atherectomy; Direct Atherectomy group	Device: plaque excision system
Active Comparator: Intervention: Balloon; Balloon group	Device: Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Technical success is defined as residual stenosis less than 30% by final angiography and/or a flow-limiting dissection.	1 day
freedom from clinically-driven TLR	it is defined as freedom from clinically-driven target lesion revascularization	12 months
Limb Salvage Rate	Limb Salvage is defined as the freedom from secondary major amputation	12 months
Major Adverse Events	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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• Yongquan G, Lianrui G, Lixing Q, Xuefeng L, Zhu T, Shijun C, Yingfeng W, Jianming G, Jian Z, Zhonggao W. Plaque excision in the management of lower-limb ischemia of atherosclerosis and in-stent restenosis with the SilverHawk atherectomy catheter. Int Angiol. 2013 Aug;32(4):362-7.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: atherectomy; In-stent Restenosis; stents; femoral artery; popliteal artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: WuanwuH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES