Clinical trial NCT04010123: Post-Market Clinical Follow Up of Rotarex®S Catheter
Official title: Post-Market Clinical Follow Up of Rotarex®S Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Straub Medical AG
Sponsor class: INDUSTRY
First posted: 2019-07-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute / Subacute / Chronic occlusions (Thrombotic / Thromboembolic / Atherothrombotic) of Native Arteries, Stents and Stents-grafts, Bypass grafts and AV-Fistula (Dialysis access))

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from major adverse events (MAE)
timeFrame: 30 days
Secondary outcomes:
measure: (MAE) Major adverse events Rate
timeFrame: 6, 12 and 24 months
measure: Technical success
timeFrame: Day 1
measure: Freedom of Target Lesion Revascularization (TLR)
timeFrame: 12 Months
measure: Freedom of Target Vessel Revascularization (TVR)
timeFrame: 1, 6, 12 and 24 Months
measure: 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).
timeFrame: From start to end of procedure
measure: Incidence of Rotarex®S Catheter -related perforations.
timeFrame: From start to end of procedure
measure: Clinical success
timeFrame: 1, 6, 12 and 24 months
measure: Hemodynamic success
timeFrame: 30 days
measure: Primary patency at 1, 6, 12 and 24 months.
timeFrame: 1, 6, 12 and 24 months
measure: Walking improvement at 1, 6, 12 and 24 months assessed by Vascu Quality of Life Questionnaire (VQ-6).
timeFrame: 1, 6, 12 and 24 months
measure: Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L)
timeFrame: 1, 6, 12 and 24 months
measure: Duration of hospital stay for index procedure [days].
timeFrame: Duration of hospital stay, up to 12 weeks
measure: Duration of ICU stay for index procedure [days].
timeFrame: Duration of ICU stay, up to 12 weeks
measure: Procedural success
timeFrame: From start to end of procedure
measure: Successful use of Arterio Venous-Fistula as dialysis access, defined as successful use of the fistula for dialysis on at least one occasion.
timeFrame: Up to 14 days
measure: 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.
timeFrame: 1, 6, 12 and 24 months
measure: (SAEs) Serious Adverse events Rate
timeFrame: 6, 12 and 24 months
measure: Procedure-related Adverse events Rate
timeFrame: 6, 12 and 24 months
measure: (ADEs) Adverse device effects Rate
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Příbram
country: Czechia
facility: Angiocentrum Příbram
city: Tallinn
country: Estonia
facility: East-Tallinn Central Hospital
city: Dijon
country: France
facility: CHU - Hôpital François-Mitterrand
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland GmbH
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Friedrichshafen
country: Germany
facility: Klinikum Friedrichshafen
city: Leipzig
country: Germany
facility: Universitätsklinik Leipzig
city: Lingen
country: Germany
facility: Bonifatius Hospital
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Radebeul
country: Germany
facility: Elblandklinikum Radebeul
city: Riesa
country: Germany
facility: Elblandklinikum Riesa
city: Torgau
country: Germany
facility: Kreiskrankenhaus Torgau "Johann Kentmann"
city: Peschiera Del Garda
country: Italy
facility: Ospedale P. Pederzoli - Casa di Cura Privata Spa
Study officials:
affiliation: Klinikum Hochsauerland GmbH
name: Michael Lichtenberg, Dr. med.
role: STUDY_DIRECTOR
References: