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

Not Applicable

Suspended

• Conditions: Critical Limb Ischemia
• Interventions: Device: Stellarex DCB; Device: PTA Catheter

• Registration Number: NCT03175744
• Lead Sponsor: Spectranetics Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-10
• Study Start: 2017-05-24
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Primary Completion: 2022-04-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 82

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellarex DCB	Stellarex DCB	Spectranetics Stellarex Drug Coated Balloon
PTA Catheter	PTA Catheter	Standard Uncoated Balloon Angioplasty Catheter

Primary Outcome Measures

Name	Time	Method
Freedom from Major Adverse Limb Event (MALE)	30 days	Composite of major amputation or major reintervention on a per patient basis
Freedom from Perioperative Death (POD)	30 days	Death on a per patient basis
Patency	6 months	Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Limb Salvage	6 months	Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

Secondary Outcome Measures

Name	Time	Method
Clinically-driven target lesion revascularization	6 months	Rate of clinically-driven target lesion revascularization
Major adverse event rates	6 months	Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
Patency rate	6 months	Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention

Trial Locations

Locations (21)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Medizinische Universitat Wien; 🇦🇹 Vienna, Austria

University Hospital Gent; 🇧🇪 Gent, Belgium

University Hospital of Tuebingen; 🇩🇪 Tuebingen, Germany

SRH Klinikum Karlsbad; 🇩🇪 Karlsbad, Germany

Bradenton Cardiology Center; 🇺🇸 Bradenton, Florida, United States

St. Joseph Hospital; 🇺🇸 Orange, California, United States

Bryn Mawr Hospital; 🇺🇸 Bryn Mawr, Pennsylvania, United States

University Hospitals, Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

LKH Universitatsklinik Graz; 🇦🇹 Graz, Austria

Flinders Medical Center; 🇦🇺 Bedford Park, Australia

Pinnacle Health Cardiovascular Institute; 🇺🇸 Wormleysburg, Pennsylvania, United States

Universitats-Herzzentrum Freiburg-Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Australia

ZOL St. jan; 🇧🇪 Genk, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Klinikum Hoschsauerland GmbH; 🇩🇪 Arnsberg, Germany

Universitatsklink Leipzig; 🇩🇪 Leipzig, Germany

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States