NCT02832024

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 4, 2019

Status Verified

May 1, 2019

Enrollment Period

3.9 years

First QC Date

September 14, 2015

Last Update Submit

December 2, 2019

Conditions

AtherosclerosisIn-stent Arterial Restenosis

Keywords

stentsatherectomyfemoral arterypopliteal arteryIn-stent Restenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Technical success

    1 day

  • freedom from clinically-driven TLR

    12 months

  • Major Adverse Events

    12 months

  • Limb Salvage Rate

    12 months

Study Arms (3)

Intervention: Stents

ACTIVE COMPARATOR

Stents group

Device: stent

Intervention: Atherectomy

ACTIVE COMPARATOR

Direct Atherectomy group

Device: plaque excision system

Intervention: Balloon

ACTIVE COMPARATOR

Balloon group

Device: Balloon

Interventions

plaque excision systemDEVICE
Intervention: Atherectomy
stentDEVICE
Intervention: Stents
BalloonDEVICE
Intervention: Balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gu Yong Quan

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23822938BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Interventions

Stents

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Central Study Contacts

li yang

CONTACT

17198643706

Gu yongquan

CONTACT

+186-010-83198647

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

September 14, 2015

First Posted

July 13, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

December 4, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)