Clinical trial NCT03175744: Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Critical Limb Ischemia
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
Collaborators: name: Philips Healthcare
First posted: 2017-06-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Freedom from Major Adverse Limb Event (MALE)
timeFrame: 30 days
measure: Freedom from Perioperative Death (POD)
timeFrame: 30 days
measure: Patency
timeFrame: 6 months
measure: Limb Salvage
timeFrame: 6 months
Secondary outcomes:
measure: Clinically-driven target lesion revascularization
timeFrame: 6 months
measure: Major adverse event rates
timeFrame: 6 months
measure: Patency rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: University Hospitals, Cleveland Medical Center
state: Ohio
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Bedford Park
country: Australia
facility: Flinders Medical Center
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
city: Graz
country: Austria
facility: LKH Universitatsklinik Graz
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Genk
country: Belgium
facility: ZOL St. jan
city: Gent
country: Belgium
facility: University Hospital Gent
city: Arnsberg
country: Germany
facility: Klinikum Hoschsauerland GmbH
city: Bad Krozingen
country: Germany
facility: Universitats-Herzzentrum Freiburg-Bad Krozingen
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad
city: Leipzig
country: Germany
facility: Universitatsklink Leipzig
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
affiliation: Lankenau Heart Institute
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vascular and Interventional Specialists of Orange
name: Mahmood K Razavi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leipzig
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
References: