SuspendedNo phase
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Key facts
- Who runs it
- Spectranetics Corporation
- Where
- Bradenton, Bryn Mawr, Cleveland, Greenville, Hackensack, Houma, New York, Orange, and Wormleysburg, United StatesSee the 9 sitesAlso in 4 other countries, 12 sites
- Trial code
- Status
- Suspended
- People taking part
- 82 people enrolled
- Started
- 24 May 2017
- Ended
- Oct 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Stellarex DCB
- PTA Catheter
- Record updated
- 22 June 2023
- Why it stopped
- Patient enrollment impacted by COVID-19 pandemic and other business challenges. Patient enrollment discontinued, but follow-ups will continue according to protocol.
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior stent placement in target lesion
- History of stroke within 3 months
- eGFR <30
- Pregnant or planning to become pregnant
- Planned major amputation
- Acute limb ischemia
Where in United States
Also in 4 other countries, 12 sites
- Bradenton Cardiology CenterBradenton, United StatesNo longer taking part
- Bryn Mawr HospitalBryn Mawr, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- Greenville Health SystemGreenville, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- Cardiovascular Institute of the SouthHouma, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
- St. Joseph HospitalOrange, United StatesNo longer taking part
- Pinnacle Health Cardiovascular InstituteWormleysburg, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Stellarex DCBTreatment being tested
Spectranetics Stellarex Drug Coated Balloon
- PTA CatheterExisting treatment, for comparison
Standard Uncoated Balloon Angioplasty Catheter
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 22 June 2023