Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Critical Limb Ischemia Clinical Trial

— ILLUMENATE-BTK  

Official title:

Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03175744
• Other study ID #: D032150
• Status: Suspended
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia

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