NCT02793492

Brief Summary

This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external iliac artery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

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

Study Progress92%
Aug 2022Sep 2026

First Submitted

Initial submission to the registry

May 16, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
6.2 years until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

May 16, 2016

Last Update Submit

March 20, 2026

Conditions

Iliac Artery Stenosis

Outcome Measures

Primary Outcomes (1)

  • Freedom from the composite Major Adverse Event rate, defined as periprocedural related death, amputation of the target limb, and clinically driven TLR assessed at 9 months post-procedure.

    9 months post-procedure

Secondary Outcomes (13)

  • Major Adverse Event rate at 30 days, and 12- and 24- months post-procedure defined as a composite of peri-procedural related death, amputation of the target limb, and clinically driven TLR.

    30 days, 12- and 24- months post-procedure

  • Primary stent patency at 9 months defined by a binary duplex ultrasound peak systolic velocity ratio ≤ 2.4 at the stented target lesion and absence of TLR.

    9 months post-procedure

  • Technical Success defined by the following conditions: 1) Successful delivery of the stent at the lesion site 2) Stent(s) successfully deployed in lesion with adequate lesion coverage

    The outcome is assessed up to 24 hours from time of enrollment through index procedure.

  • Procedural Success: Attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications.

    The outcome is assessed up to 24 hours from time of enrollment through index procedure

  • Clinical Success: Relief or improvement (without increase of one or more in the score) from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline.

    30 days post-procedure

  • +8 more secondary outcomes

Study Arms (1)

Misago® RX Self-expanding Stent

EXPERIMENTAL

Eligible participants will undergo stent implantation with the Misago® RX Self-expanding Stent

Device: Misago® RX Self-expanding Peripheral Stent

Interventions

Misago® RX Self-expanding Peripheral StentDEVICE

the Misago® RX Self-expanding Stent is a bare metal, nitinol stent

Misago® RX Self-expanding Stent

Eligibility Criteria

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

You may qualify if:

  • Is ≥ 18 years old and of legal consent.
  • Is willing to comply with all follow-up evaluations at the specified times.
  • Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
  • Has a Rutherford Clinical Category Score of 2, 3 or 4.
  • Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery.

You may not qualify if:

  • Has had previous stent or stent-graft implantation in the target lesion(s).
  • Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol.
  • Has known hypersensitivity to contrast material that cannot be adequately pretreated.
  • Has known hypersensitivity to nickel-titanium (nitinol).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

ClinRe Inc. Advanced Heart and Vein Center

Thornton, Colorado, 80023, United States

Location

University of Florida Health

Gainesville, Florida, 32610, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Cardiovascular Institute of the South

Lafayette, Louisiana, 70506, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Novant Health

Matthews, North Carolina, 28105, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Study Officials

  • John Rundback, MD

    Holy Name Medical Center

    PRINCIPAL INVESTIGATOR

  • Charis Sugden

    Terumo Medical Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

June 8, 2016

Study Start

August 30, 2022

Primary Completion

February 24, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

US(9)