Post-Market Clinical Follow Up of Rotarex®S Catheter

Straub Medical

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Atherectomy/Thrombectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT04010123

PMCF-001

Details and patient eligibility

About

Post-Market Clinical Follow Up of the Rotarex®S Catheter

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is ≥18 years old at the time of consent.

2. 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.

3. Female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure.

4. Documented symptomatic peripheral arterial disease.

5. 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).

6. De novo or re-occluded lesion.

7. Vessel and/or stent diameter within treatable range as per Instruction For Use.

8. Occlusion crossed intraluminally by a guidewire.

   For patients requiring lower limb intervention:

9. 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

1. Life expectancy < 2 years.
2. Pregnant or nursing a child.
3. Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated.
4. Myocardial infarction within 60 days prior to index procedure.
5. History of severe trauma and/or sepsis within 60 days prior to index procedure.
6. Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure.
7. Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure.
8. 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.
9. Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only).
10. Additional lesion that is located >3cm away from the target lesion
11. Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter.
12. Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
13. Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
14. Patients with uncorrected bleeding disorders.
15. Thrombophlebitis or deep vein thrombosis within the past 30 days.