An observational study in Atherosclerotic Disease, sponsored by Klinikum Arnsberg. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-09.
Sponsored by Klinikum Arnsberg · Observational
A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.
Interim analysis will be carried out for every 50 subjects enrolled.
Klinikum Arnsberg is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon and who fulfill the in/exclusion criteria at approved investigational centres are eligible for participation in the Ranger DEB-Comers Registry.
Exclusion Criteria:
Patients implanted or scheduled for an implant with a Ranger Drug coated balloon.
Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.
Time frame: 6 Months
Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
Time frame: 12 Months
Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention
Time frame: 6 and 24 Months
MAE at 12 and 24 months
Time frame: 12 and 24 Months
Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)
Time frame: Intraoperative
Device success, defined as exact deployment of the device according to the IFU (operator assessment)
Time frame: Intraoperative
Procedural success, defined as the combination of technical success and device success
Time frame: Intraoperative
Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)
Time frame: 6, 12 and 24 months
Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.
Time frame: 6, 12 and 24 months
Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.
Time frame: 6, 12 and 24 months
Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.
Time frame: 6, 12 and 24 months
Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score
Time frame: 6, 12 and 24 months
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Klinikum Arnsberg