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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03175744
Other study ID # D032150
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date May 24, 2017
Est. completion date October 2025

Study information

Verified date June 2023
Source Spectranetics Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 82
Est. completion date October 2025
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Stellarex DCB
Intervention with the Stellarex DCB
PTA Catheter
Intervention with an uncoated Standard PTA

Locations

Country Name City State
Australia Flinders Medical Center Bedford Park
Australia Sir Charles Gairdner Hospital Perth
Austria LKH Universitatsklinik Graz Graz
Austria Medizinische Universitat Wien Vienna
Belgium Imelda Ziekenhuis Bonheiden
Belgium ZOL St. jan Genk
Belgium University Hospital Gent Gent
Germany Klinikum Hoschsauerland GmbH Arnsberg
Germany Universitats-Herzzentrum Freiburg-Bad Krozingen Bad Krozingen
Germany SRH Klinikum Karlsbad Karlsbad
Germany Universitatsklink Leipzig Leipzig
Germany University Hospital of Tuebingen Tuebingen
United States Bradenton Cardiology Center Bradenton Florida
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States University Hospitals, Cleveland Medical Center Cleveland Ohio
United States Greenville Health System Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Cardiovascular Institute of the South Houma Louisiana
United States Icahn School of Medicine at Mount Sinai New York New York
United States St. Joseph Hospital Orange California
United States Pinnacle Health Cardiovascular Institute Wormleysburg Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Spectranetics Corporation Philips Healthcare

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from Major Adverse Limb Event (MALE) Composite of major amputation or major reintervention on a per patient basis 30 days
Primary Freedom from Perioperative Death (POD) Death on a per patient basis 30 days
Primary Patency Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis 6 months
Primary 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 Clinically-driven target lesion revascularization Rate of clinically-driven target lesion revascularization 6 months
Secondary Major adverse event rates Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention 6 months
Secondary Patency rate Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention 6 months
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