An interventional study of Ranger DCB and uncoated PTA balloon in Peripheral Artery Disease, Claudication and Atherosclerosis, sponsored by Hemoteq AG. Completed at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-23.
Sponsored by Hemoteq AG · Not applicable, Interventional, and Treatment
The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 105 is close to the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Hemoteq AG is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Index lesion treated with Ranger(TM) Paclitaxel-coated PTA balloon catheter (Ranger DCB)
Device: Ranger DCB
Index lesion treated with an uncoated standard PTA dilatation balloon catheter selected upon investigator´s discretion
Device: uncoated PTA balloon
After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion. If two devices are deployed, overlap shall be minimal.
The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.
in-segment late lumen loss
In-segment late lumen loss (LLL) of the treated segment after PTA using the Ranger™ paclitaxel-coated PTA balloon, in comparison to the LLL after PTA using an uncoated balloon, as observed by angiography at six months post-index procedure.
Time frame: six months
technical success
The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
Time frame: during index procedure, less 1 hour
procedural success
Technical success with no MAE noted within 24 hours of the index procedure.
Time frame: within 24 hours of index procedure
primary patency
Percentage of lesions that reach endpoint without a hemodynamically significant stenosis on duplex ultrasound (DUS) and without target lesion revascularization (TLR) or bypass of the target lesion to maintain or restore patency.
Time frame: six months
primary patency
Percentage of lesions that reach endpoint without a hemodynamically significant stenosis on DUS and without TLR or bypass of the target lesion to maintain or restore patency.
Time frame: twelve months
assisted primary patency
Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.
Time frame: six months
assisted primary patency
Percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach endpoint without restenosis.
Time frame: twelve months
secondary patency
Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.
Time frame: six months
secondary patency
Percentage of lesions with TLR for occlusion that reach endpoint without restenosis.
Time frame: twelve months
binary restenosis rate
Binary restenosis defined as \> 50% diameter stenosis via peak systolic velocity ratio (PSVR) \> 2.4 via duplex ultrasound and assessed by the core lab.
Time frame: six months
binary restenosis rate
Binary restenosis defined as \> 50% diameter stenosis via peak systolic velocity ratio (PSVR) \> 2.4 via duplex ultrasound and assessed by the core lab.
Time frame: twelve months
clinical success
Positive change (by +1 or more) of Rutherford category at pre-discharge post-index-procedure as compared to baseline.
Time frame: pre-discharge, estim. 1-2 days post-index procedure
clinical success
Positive change (by +1 or more) of Rutherford category at six months (plus or minus 30 days) post-index-procedure as compared to baseline.
Time frame: six months
clinical success
Positive change (by +1 or more) of Rutherford category at twelve months (plus or minus 30 days) post-index-procedure as compared to baseline.
Time frame: twelve months
hemodynamic success
positive change in Ankle-Brachial Index (ABI) at pre-discharge as compared to baseline
Time frame: pre-discharge, estim. 1-2 days post-index procedure
hemodynamic success
positive change in ABI at six months (plus or minus 30 days) as compared to baseline
Time frame: six months
hemodynamic success
positive change in ABI at twelve months (plus or minus 30 days) as compared to baseline
Time frame: twelve months
change in quality of life
Change in functional status measured by changes in the Walking Impairment Questionnaire (WiQ) and general health-related quality of life measured by changes in SF-12 and EQ5D scores at six months (plus or minus 30 days) as compared to baseline.
Time frame: six months
change in quality of life
Change in functional status measured by changes in the Walking Impairment Questionnaire (WiQ) and general health-related quality of life measured by changes in SF-12 and EQ5D scores at twelve months (plus or minus 30 days) as compared to baseline.
Time frame: twelve months
change in quality of life
Change in general health-related quality of life measured by changes in SF-12 and EQ5D scores at 24 months (plus or minus 30 days) as compared to baseline.
Time frame: 24 months
change in quality of life
Change in general health-related quality of life measured by changes in SF-12 and EQ5D scores at 36 months (plus or minus 30 days) as compared to baseline.
Time frame: 36 months
Plan to share: No
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Hemoteq AG