Status:
COMPLETED
Post-Market Clinical Follow Up of Rotarex®S Catheter
Lead Sponsor:
Straub Medical AG
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Brief Summary
Post-Market Clinical Follow Up of the Rotarex®S Catheter
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 e...
Eligibility Criteria
Inclusion
- Patient is ≥18 years old at the time of consent.
- 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.
- Female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure.
- Documented symptomatic peripheral arterial disease.
- 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).
- De novo or re-occluded lesion.
- Vessel and/or stent diameter within treatable range as per Instruction For Use.
- 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
- Life expectancy \< 2 years.
- Pregnant or nursing a child.
- Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated.
- Myocardial infarction within 60 days prior to index procedure.
- History of severe trauma and/or sepsis within 60 days prior to index procedure.
- Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure.
- Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure.
- 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.
- Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only).
- Additional lesion that is located \>3cm away from the target lesion
- Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter.
- Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
- Patients with uncorrected bleeding disorders.
- Thrombophlebitis or deep vein thrombosis within the past 30 days.
Key Trial Info
Start Date :
July 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 26 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04010123
Start Date
July 17 2019
End Date
October 26 2022
Last Update
February 9 2023
Active Locations (13)
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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