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Post-Market Clinical Follow Up of Rotarex®S Catheter

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ClinicalTrials.gov Identifier: NCT04010123
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Straub Medical AG

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

Condition or disease Intervention/treatment
Peripheral Arterial Disease Device: Atherectomy/Thrombectomy

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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Clinical Follow Up of Rotarex®S Catheter
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Intervention Details:
  • Device: Atherectomy/Thrombectomy
    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.


Primary Outcome Measures :
  1. Freedom from major adverse events (MAE) [ Time Frame: 30 days ]
    Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.


Secondary Outcome Measures :
  1. (MAE) Major adverse events Rate [ Time Frame: 6, 12 and 24 months ]
    Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.

  2. Technical success [ Time Frame: 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.

  3. Freedom of Target Lesion Revascularization (TLR) [ Time Frame: 12 Months ]
    Freedom of Target Lesion Revascularization (TLR)

  4. Freedom of Target Vessel Revascularization (TVR) [ Time Frame: 1, 6, 12 and 24 Months ]
    Freedom of Target Vessel Revascularization (TVR)

  5. 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). [ Time Frame: 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).

  6. Incidence of Rotarex®S Catheter -related perforations. [ Time Frame: From start to end of procedure ]
    Rotarex®S Catheter -related perforations.

  7. Clinical success [ Time Frame: 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.

  8. Hemodynamic success [ Time Frame: 30 days ]
    Defined as a > 0.15 improvement in ABI (ankle-brachial index) at 30 days with reference to the baseline value.

  9. Primary patency at 1, 6, 12 and 24 months. [ Time Frame: 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).

  10. Walking improvement at 1, 6, 12 and 24 months assessed by Vascu Quality of Life Questionnaire (VQ-6). [ Time Frame: 1, 6, 12 and 24 months ]
    Walking improvement assessed by Vascu Quality of Life Questionnaire (VQ-6)

  11. Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L) [ Time Frame: 1, 6, 12 and 24 months ]
    Improvement of quality of life assessed by Questionnaire (EQ5D-3L)

  12. Duration of hospital stay for index procedure [days]. [ Time Frame: Duration of hospital stay, up to 12 weeks ]
    Number of day from admission to discharge from hospital.

  13. Duration of ICU stay for index procedure [days]. [ Time Frame: Duration of ICU stay, up to 12 weeks ]
    Number of day from admission to discharge from intensive care unit.

  14. Procedural success [ Time Frame: 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.

  15. Successful use of Arterio Venous-Fistula as dialysis access, defined as successful use of the fistula for dialysis on at least one occasion. [ Time Frame: Up to 14 days ]
    Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.

  16. 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. [ Time Frame: 1, 6, 12 and 24 months ]
    Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.

  17. (SAEs) Serious Adverse events Rate [ Time Frame: 6, 12 and 24 months ]
    SAEs as defined per ISO 14155.

  18. Procedure-related Adverse events Rate [ Time Frame: 6, 12 and 24 months ]
    Procedure-related AEs as defined per ISO 14155.

  19. (ADEs) Adverse device effects Rate [ Time Frame: 6, 12 and 24 months ]
    Adverse device effects (ADEs) as defined per ISO 14155.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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))
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010123


Contacts
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Contact: Torsten Böhler, Dr. 81 720 05 12 ext 0041 torsten.boehler@straubmedical.com
Contact: Walter Mayerl, Dr. 81 720 05 34 ext 0041 Walter.Mayerl@straubmedical.com

Locations
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France
CHU - Hôpital François-Mitterrand Not yet recruiting
Dijon, France
Contact: Romaric Loffroy, MD. PhD         
Principal Investigator: Romaric Loffroy, MD. PhD         
Germany
Klinikum Hochsauerland GmbH Recruiting
Arnsberg, Germany, 59759
Contact: Michael Lichtenberg, Dr. med.         
Bonifatius Hospital Recruiting
Lingen, Germany
Contact: Jörg Tessarek, MD         
Principal Investigator: Jörg Tessarek, MD         
Kreiskrankenhaus Torgau "Johann Kentmann" Not yet recruiting
Torgau, Germany
Contact: Lars Maiwald, MD         
Principal Investigator: Lars Maiwald, MD         
Sponsors and Collaborators
Straub Medical AG
Investigators
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Study Director: Michael Lichtenberg, Dr. med. Klinikum Hochsauerland GmbH

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Responsible Party: Straub Medical AG
ClinicalTrials.gov Identifier: NCT04010123     History of Changes
Other Study ID Numbers: PMCF-001
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases