Post-Market Clinical Follow Up of Rotarex®S Catheter
Study Details
Study Description
Brief Summary
Post-Market Clinical Follow Up of the Rotarex®S Catheter
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
- Freedom from major adverse events (MAE) [30 days]
Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.
Secondary Outcome Measures
- (MAE) Major adverse events Rate [6, 12 and 24 months]
Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.
- Technical success [Day 1]
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.
- Freedom of Target Lesion Revascularization (TLR) [12 Months]
Freedom of Target Lesion Revascularization (TLR)
- Freedom of Target Vessel Revascularization (TVR) [1, 6, 12 and 24 Months]
Freedom of Target Vessel Revascularization (TVR)
- 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). [From start to end of procedure]
Rotarex®S Catheter -related distal embolization requiring further treatment with pharmacologic or mechanical devices (except treating with intravascular nipride or nitroglycerin).
- Incidence of Rotarex®S Catheter -related perforations. [From start to end of procedure]
Rotarex®S Catheter -related perforations.
- Clinical success [1, 6, 12 and 24 months]
Defined as clinical category improvement in the Rutherford Class at 1, 6, 12 and 24 months with reference to the baseline value.
- Hemodynamic success [30 days]
Defined as a > 0.15 improvement in ABI (ankle-brachial index) at 30 days with reference to the baseline value.
- Primary patency at 1, 6, 12 and 24 months. [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).
- Walking improvement at 1, 6, 12 and 24 months assessed by Vascu Quality of Life Questionnaire (VQ-6). [1, 6, 12 and 24 months]
Walking improvement assessed by Vascu Quality of Life Questionnaire (VQ-6)
- Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L) [1, 6, 12 and 24 months]
Improvement of quality of life assessed by Questionnaire (EQ5D-3L)
- Duration of hospital stay for index procedure [days]. [Duration of hospital stay, up to 12 weeks]
Number of day from admission to discharge from hospital.
- Duration of ICU stay for index procedure [days]. [Duration of ICU stay, up to 12 weeks]
Number of day from admission to discharge from intensive care unit.
- Procedural success [From start to end of procedure]
Successful revascularization of target lesion defined as ≤30% residual angiographic diameter stenosis following Rotarex®S Catheter treatment ± adjunctive treatment.
- Successful use of Arterio Venous-Fistula as dialysis access, defined as successful use of the fistula for dialysis on at least one occasion. [Up to 14 days]
Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.
- 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. [1, 6, 12 and 24 months]
Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.
- (SAEs) Serious Adverse events Rate [6, 12 and 24 months]
SAEs as defined per ISO 14155.
- Procedure-related Adverse events Rate [6, 12 and 24 months]
Procedure-related AEs as defined per ISO 14155.
- (ADEs) Adverse device effects Rate [6, 12 and 24 months]
Adverse device effects (ADEs) as defined per ISO 14155.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is ≥18 years old at the time of consent.
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Subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments.
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Female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure.
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Documented symptomatic peripheral arterial disease.
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Acute, subacute and chronic (sub-) occlusion, with ≥ 90% stenosis in native arteries and/or stents / stent grafts and/or Bypass grafts and/or AV Fistula (Dialysis access).
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De novo or re-occluded lesion.
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Vessel and/or stent diameter within treatable range as per Instruction For Use.
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Occlusion crossed intraluminally by a guidewire.
For patients requiring lower limb intervention:
- Patient presenting with a category from 2 to 5 according to the Rutherford classification for chronic limb ischemia or a category from I to IIb according to the Rutherford classification for acute limb ischemia.
Exclusion Criteria:
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Life expectancy < 2 years.
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Pregnant or nursing a child.
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Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated.
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Myocardial infarction within 60 days prior to index procedure.
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History of severe trauma and/or sepsis within 60 days prior to index procedure.
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Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure.
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Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure.
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Abnormal electrocardiogram or blood test results and/or any other factor that would increase risk by participating in the study in the opinion of the investigator.
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Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only).
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Additional lesion that is located >3cm away from the target lesion
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Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter.
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Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
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Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
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Patients with uncorrected bleeding disorders.
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Thrombophlebitis or deep vein thrombosis within the past 30 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Angiocentrum Příbram | Příbram | Czechia | ||
| 2 | East-Tallinn Central Hospital | Tallinn | Estonia | ||
| 3 | CHU - Hôpital François-Mitterrand | Dijon | France | ||
| 4 | Klinikum Hochsauerland GmbH | Arnsberg | Germany | 59759 | |
| 5 | Universitäts-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | Germany | ||
| 6 | Klinikum Friedrichshafen | Friedrichshafen | Germany | ||
| 7 | Universitätsklinik Leipzig | Leipzig | Germany | ||
| 8 | Bonifatius Hospital | Lingen | Germany | ||
| 9 | Universitätsklinikum Münster | Münster | Germany | ||
| 10 | Elblandklinikum Radebeul | Radebeul | Germany | ||
| 11 | Elblandklinikum Riesa | Riesa | Germany | ||
| 12 | Kreiskrankenhaus Torgau "Johann Kentmann" | Torgau | Germany | ||
| 13 | Ospedale P. Pederzoli - Casa di Cura Privata Spa | Peschiera Del Garda | Italy |
Sponsors and Collaborators
- Straub Medical AG
Investigators
- Study Director: Michael Lichtenberg, Dr. med., Klinikum Hochsauerland GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMCF-001