An interventional study of Stellarex DCB and PTA Catheter in Critical Limb Ischemia, sponsored by Spectranetics Corporation. Suspended at 21 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Spectranetics Corporation (part of Philips) · Not applicable, Interventional, and Treatment
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.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's enrollment of 82 is above the median of 40 across 239 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Spectranetics Corporation is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted before Spectranetics Corporation became part of Philips.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Spectranetics Stellarex Drug Coated Balloon
Device: Stellarex DCB
Standard Uncoated Balloon Angioplasty Catheter
Device: PTA Catheter
Intervention with the Stellarex DCB
Intervention with an uncoated Standard PTA
Freedom from Major Adverse Limb Event (MALE)
Composite of major amputation or major reintervention on a per patient basis
Time frame: 30 days
Freedom from Perioperative Death (POD)
Death on a per patient basis
Time frame: 30 days
Patency
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Time frame: 6 months
Limb Salvage
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Time frame: 6 months
Clinically-driven target lesion revascularization
Rate of clinically-driven target lesion revascularization
Time frame: 6 months
Major adverse event rates
Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
Time frame: 6 months
Patency rate
Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is suspended, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia →