Post-Market Clinical Follow Up of Rotarex®S Catheter

NCT04010123 | Completed

• 1 other identifier: PMCF-001
• Study Type: observational
• Target: 220
• Locations: 5 countries
• Sites: 13

Brief Summary

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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Freedom from major adverse events (MAE)

  Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.

  30 days

Secondary Outcomes (19)

• (MAE) Major adverse events Rate

  6, 12 and 24 months

• Technical success

  Day 1

• Freedom of Target Lesion Revascularization (TLR)

  12 Months

• Freedom of Target Vessel Revascularization (TVR)

  1, 6, 12 and 24 Months

• 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

Interventions

Atherectomy/Thrombectomy DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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))

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Straub Medical AG: lead

Study Sites (13)

Angiocentrum Příbram

Příbram, Czechia

Location

East-Tallinn Central Hospital

Tallinn, Estonia

Location

CHU - Hôpital François-Mitterrand

Dijon, France

Location

Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Location

Klinikum Friedrichshafen

Friedrichshafen, Germany

Location

Universitätsklinik Leipzig

Leipzig, Germany

Location

Bonifatius Hospital

Lingen, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Elblandklinikum Radebeul

Radebeul, Germany

Location

Elblandklinikum Riesa

Riesa, Germany

Location

Kreiskrankenhaus Torgau "Johann Kentmann"

Torgau, Germany

Location

Ospedale P. Pederzoli - Casa di Cura Privata Spa

Peschiera del Garda, Italy

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Atherectomy; Thrombectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Michael Lichtenberg, Dr. med.

  Klinikum Hochsauerland GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: July 8, 2019
• Study Start: July 17, 2019
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: February 9, 2023

Record last verified: 2020-12

Locations

IT (1); ES (1); DE (9); FR (1); CZ (1)