Post-Market Clinical Follow Up of the Rotarex®S Catheter
A prospective, multi-center, non-randomized, multiple cohorts, observational, post market clinical follow-up study of the Rotarex®S Catheter to evaluate the safety, technical performance and medical efficacy of the Rotarex®S Catheter as a stand-alone and adjunctive therapy for the treatment of acute, subacute and chronic occlusions and sub-occlusions of arteries outside the cardiopulmonary, coronary and cerebral circulations, in accordance with Rotarex®S Catheter intended use.
Study Type
OBSERVATIONAL
Enrollment
220
Percutaneous transluminal removal of thrombotic, thromboembolic and atherothrombotic material from fresh, subacute and chronic occlusions of blood vessels in native blood vessels or vessels fitted with stents, stent grafts or native or artificial bypasses.
Angiocentrum Příbram
Příbram, Czechia
East-Tallinn Central Hospital
Tallinn, Estonia
CHU - Hôpital François-Mitterrand
Dijon, France
Freedom from major adverse events (MAE)
Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.
Time frame: 30 days
(MAE) Major adverse events Rate
Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.
Time frame: 6, 12 and 24 months
Technical success
defined as the ability to cross and treat the target lesion with the Rotarex®S Catheter to achieve residual angiographic stenosis no greater than 50% directly after Rotarex®S Catheter use.
Time frame: Day 1
Freedom of Target Lesion Revascularization (TLR)
Freedom of Target Lesion Revascularization (TLR)
Time frame: 12 Months
Freedom of Target Vessel Revascularization (TVR)
Freedom of Target Vessel Revascularization (TVR)
Time frame: 1, 6, 12 and 24 Months
Incidence of clinically significant Rotarex®S Catheter -related distal embolization requiring further treatment with pharmacologic or mechanical devices (except treating with intravascular nipride or nitroglycerin).
Rotarex®S Catheter -related distal embolization requiring further treatment with pharmacologic or mechanical devices (except treating with intravascular nipride or nitroglycerin).
Time frame: From start to end of procedure
Incidence of Rotarex®S Catheter -related perforations.
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Klinikum Hochsauerland GmbH
Arnsberg, Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Germany
Klinikum Friedrichshafen
Friedrichshafen, Germany
Universitätsklinik Leipzig
Leipzig, Germany
Bonifatius Hospital
Lingen, Germany
Universitätsklinikum Münster
Münster, Germany
Elblandklinikum Radebeul
Radebeul, Germany
...and 3 more locations
Rotarex®S Catheter -related perforations.
Time frame: From start to end of procedure
Clinical success
Defined as clinical category improvement in the Rutherford Class at 1, 6, 12 and 24 months with reference to the baseline value.
Time frame: 1, 6, 12 and 24 months
Hemodynamic success
Defined as a \> 0.15 improvement in ABI (ankle-brachial index) at 30 days with reference to the baseline value.
Time frame: 30 days
Primary patency at 1, 6, 12 and 24 months.
Defined as freedom from \>50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \< 2.5 in the target vessel with no clinically driven target lesion revascularization (TLR).
Time frame: 1, 6, 12 and 24 months
Walking improvement at 1, 6, 12 and 24 months assessed by Vascu Quality of Life Questionnaire (VQ-6).
Walking improvement assessed by Vascu Quality of Life Questionnaire (VQ-6)
Time frame: 1, 6, 12 and 24 months
Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L)
Improvement of quality of life assessed by Questionnaire (EQ5D-3L)
Time frame: 1, 6, 12 and 24 months
Duration of hospital stay for index procedure [days].
Number of day from admission to discharge from hospital.
Time frame: Duration of hospital stay, up to 12 weeks
Duration of ICU stay for index procedure [days].
Number of day from admission to discharge from intensive care unit.
Time frame: Duration of ICU stay, up to 12 weeks
Procedural success
Successful revascularization of target lesion defined as ≤30% residual angiographic diameter stenosis following Rotarex®S Catheter treatment ± adjunctive treatment.
Time frame: From start to end of procedure
Successful use of Arterio Venous-Fistula as dialysis access, defined as successful use of the fistula for dialysis on at least one occasion.
Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.
Time frame: Up to 14 days
Number of patients whose hemodialysis is efficient at 1, 6, 12 and 24 months without needing further treatment of the stenotic site after Rotarex®S treatment of the Arterio Venous-Fistula.
Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.
Time frame: 1, 6, 12 and 24 months
(SAEs) Serious Adverse events Rate
SAEs as defined per ISO 14155.
Time frame: 6, 12 and 24 months
Procedure-related Adverse events Rate
Procedure-related AEs as defined per ISO 14155.
Time frame: 6, 12 and 24 months
(ADEs) Adverse device effects Rate
Adverse device effects (ADEs) as defined per ISO 14155.
Time frame: 6, 12 and 24 months