SELUTION SLR™ 018 DEB for Peripheral Arterial Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Peripheral Arterial Disease+1 MoreSELUTION SLR™ 018 DEB - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Eligible Conditions
  • Peripheral Arterial Disease
  • Superficial Femoral Artery Stenosis

Treatment Effectiveness

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Freedom from target limb above-ankle amputation and clinically-driven target lesion revascularization (CD-TLR) at 12 months.
Interventional procedure
30 days
Freedom from death (device and procedure related) through 30 days post-index procedure

Trial Safety

Trial Design

2 Treatment Groups

Plain (Uncoated) Balloon Angioplasty (PTA)
1 of 2
SELUTION SLR™ 018 DEB
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: SELUTION SLR™ 018 DEB · No Placebo Group · N/A

SELUTION SLR™ 018 DEB
Device
Experimental Group · 1 Intervention: SELUTION SLR™ 018 DEB · Intervention Types: Device
Plain (Uncoated) Balloon Angioplasty (PTA)
Device
ActiveComparator Group · 1 Intervention: Plain (Uncoated) Balloon Angioplasty (PTA) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

NAMSAOTHER
30 Previous Clinical Trials
13,207 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
159 Patients Enrolled for Peripheral Arterial Disease
M.A. Med Alliance S.A.Lead Sponsor
7 Previous Clinical Trials
5,031 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
1,203 Patients Enrolled for Peripheral Arterial Disease

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be female and of childbearing potential.
You have a target lesion within the superficial femoral artery and/or proximal popliteal artery.
You have a total occlusion with lesion length between 3 and 10 centimeters.
Documented ischemia with Rutherford classification category 2, 3 or 4.
You have at least one target lesion in the SFA or PPA.
You are willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
You have a lesion of 70-99% stenosis with lesion length between 3 and 20 cm.