NCT03175744

Brief Summary

The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

Trial Health

37
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

19 active sites

Status
suspended

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

March 10, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4.9 years

First QC Date

March 10, 2017

Last Update Submit

June 21, 2023

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (4)

  • Freedom from Major Adverse Limb Event (MALE)

    Composite of major amputation or major reintervention on a per patient basis

    30 days

  • Freedom from Perioperative Death (POD)

    Death on a per patient basis

    30 days

  • Patency

    Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

    6 months

  • Limb Salvage

    Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

    6 months

Secondary Outcomes (3)

  • Clinically-driven target lesion revascularization

    6 months

  • Major adverse event rates

    6 months

  • Patency rate

    6 months

Study Arms (2)

Stellarex DCB

EXPERIMENTAL

Spectranetics Stellarex Drug Coated Balloon

Device: Stellarex DCB

PTA Catheter

ACTIVE COMPARATOR

Standard Uncoated Balloon Angioplasty Catheter

Device: PTA Catheter

Interventions

Stellarex DCBDEVICE

Intervention with the Stellarex DCB

Stellarex DCB
PTA CatheterDEVICE

Intervention with an uncoated Standard PTA

PTA Catheter

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rutherford Clinical Category 4-5
  • Life expectancy \> 1 year
  • Significant stenosis ≥70%
  • Patent inflow artery
  • Target vessel(s) diameter between 2 and 4 mm
  • Target vessel(s) reconstitute(s) at the ankle

You may not qualify if:

  • Pregnant or planning to become pregnant
  • History of stroke within 3 months
  • Planned major amputation
  • eGFR \<30
  • Acute limb ischemia
  • Prior stent placement in target lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

St. Joseph Hospital

Orange, California, 92868, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

Flinders Medical Center

Bedford Park, Australia

Location

Sir Charles Gairdner Hospital

Perth, Australia

Location

LKH Universitatsklinik Graz

Graz, Austria

Location

Medizinische Universitat Wien

Vienna, Austria

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

ZOL St. jan

Genk, Belgium

Location

University Hospital Gent

Ghent, Belgium

Location

Klinikum Hoschsauerland GmbH

Arnsberg, Germany

Location

Universitats-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, Germany

Location

SRH Klinikum Karlsbad

Karlsbad, 76307, Germany

Location

Universitatsklink Leipzig

Leipzig, Germany

Location

University Hospital of Tuebingen

Tübingen, Germany

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • William Gray, MD

    Lankenau Heart Institute

    PRINCIPAL INVESTIGATOR

  • Mahmood K Razavi, MD

    Vascular and Interventional Specialists of Orange

    PRINCIPAL INVESTIGATOR

  • Dierk Scheinert, MD

    University of Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

June 5, 2017

Study Start

May 24, 2017

Primary Completion

April 30, 2022

Study Completion

October 1, 2025

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)AU(2)DE(5)US(9)