Peripheral Arterial DiseaseNCT04010123
Post-Market Clinical Follow Up of Rotarex®S Catheter
An observational study of Peripheral Arterial Disease, run by Straub Medical AG at 13 sites in 5 countries.
Trial summary
Post-Market Clinical Follow Up of the Rotarex®S Catheter Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Atherectomy/Thrombectomy
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 17 Jul 2019to 26 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute / Subacute / Chronic occlusions (Thrombotic / Thromboembolic / Atherothrombotic) of Native Arteries, Stents and Stents-grafts, Bypass grafts and AV-Fistula (Dialysis access))
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Germany9 sites
Klinikum Hochsauerland GmbH
Arnsberg, 59759
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen
Klinikum Friedrichshafen
Friedrichshafen
Universitätsklinik Leipzig
Leipzig
Bonifatius Hospital
Lingen
Universitätsklinikum Münster
Münster
Elblandklinikum Radebeul
Radebeul
Elblandklinikum Riesa
Riesa
Kreiskrankenhaus Torgau "Johann Kentmann"
Torgau
Italy1 site
Ospedale P. Pederzoli - Casa di Cura Privata Spa
Peschiera del Garda
About this study
Post-Market Clinical Follow Up of the Rotarex®S Catheter
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Atherectomy/Thrombectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atherectomy/ThrombectomyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (19)
(MAE) Major adverse events Rate
Defined as clinically driven target lesion revascularization (TLR), any death and any unplanned major amputation of the index limb.
Measured: 6, 12 and 24 months
Technical success
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.
Measured: Day 1
Freedom of Target Lesion Revascularization (TLR)
Freedom of Target Lesion Revascularization (TLR)
Measured: 12 Months
Freedom of Target Vessel Revascularization (TVR)
Freedom of Target Vessel Revascularization (TVR)
Measured: 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).
Rotarex®S Catheter -related distal embolization requiring further treatment with pharmacologic or mechanical devices (except treating with intravascular nipride or nitroglycerin).
Measured: From start to end of procedure
Incidence of Rotarex®S Catheter -related perforations.
Rotarex®S Catheter -related perforations.
Measured: From start to end of procedure
Clinical success
Defined as clinical category improvement in the Rutherford Class at 1, 6, 12 and 24 months with reference to the baseline value.
Measured: 1, 6, 12 and 24 months
Hemodynamic success
Defined as a > 0.15 improvement in ABI (ankle-brachial index) at 30 days with reference to the baseline value.
Measured: 30 days
Primary patency at 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).
Measured: 1, 6, 12 and 24 months
Walking improvement at 1, 6, 12 and 24 months assessed by Vascu Quality of Life Questionnaire (VQ-6).
Walking improvement assessed by Vascu Quality of Life Questionnaire (VQ-6)
Measured: 1, 6, 12 and 24 months
Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L)
Improvement of quality of life assessed by Questionnaire (EQ5D-3L)
Measured: 1, 6, 12 and 24 months
Duration of hospital stay for index procedure [days].
Number of day from admission to discharge from hospital.
Measured: Duration of hospital stay, up to 12 weeks
Duration of ICU stay for index procedure [days].
Number of day from admission to discharge from intensive care unit.
Measured: Duration of ICU stay, up to 12 weeks
Procedural success
Successful revascularization of target lesion defined as ≤30% residual angiographic diameter stenosis following Rotarex®S Catheter treatment ± adjunctive treatment.
Measured: From start to end of procedure
Successful use of Arterio Venous-Fistula as dialysis access, defined as successful use of the fistula for dialysis on at least one occasion.
Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.
Measured: Up to 14 days
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.
Only for patient subject to Arterio Venous-Fistula treatment with Rotarex®S Catheter.
Measured: 1, 6, 12 and 24 months
(SAEs) Serious Adverse events Rate
SAEs as defined per ISO 14155.
Measured: 6, 12 and 24 months
Procedure-related Adverse events Rate
Procedure-related AEs as defined per ISO 14155.
Measured: 6, 12 and 24 months
(ADEs) Adverse device effects Rate
Adverse device effects (ADEs) as defined per ISO 14155.
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start17 Jul 2019
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Straub Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lichtenberg, Dr. med., Study director, Klinikum Hochsauerland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010123
- Sponsor's protocol ID
- PMCF-001
- Status last verified
- Dec 2020
- First submitted
- 10 May 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow Up of Rotarex®S Catheter
- ClinicalTrials.gov ID
- NCT04010123
- Acronym / sponsor ID
- PMCF-001
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Straub Medical AGIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute / Subacute / Chronic occlusions (Thrombotic / Thromboembolic / Atherothrombotic) of Native Arteries, Stents and Stents-grafts, Bypass grafts and AV-Fistula (Dialysis access))
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atherectomy/ThrombectomyPercutaneous 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. | Device | – |
Primary outcome
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.
19 secondary outcomes
(MAE) Major adverse events Rate
Time frame: 6, 12 and 24 months
Technical success
Time frame: Day 1
Freedom of Target Lesion Revascularization (TLR)
Time frame: 12 Months
Freedom of Target Vessel Revascularization (TVR)
Time frame: 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).
Time frame: From start to end of procedure
Incidence of Rotarex®S Catheter -related perforations.
Time frame: From start to end of procedure
Clinical success
Time frame: 1, 6, 12 and 24 months
Hemodynamic success
Time frame: 30 days
Primary patency at 1, 6, 12 and 24 months.
Time frame: 1, 6, 12 and 24 months
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
Quality of Life improvement at 1, 6, 12 and 24 months assessed by Questionnaire. (EQ5D-3L)
Time frame: 1, 6, 12 and 24 months
Duration of hospital stay for index procedure [days].
Time frame: Duration of hospital stay, up to 12 weeks
Duration of ICU stay for index procedure [days].
Time frame: Duration of ICU stay, up to 12 weeks
Procedural success
Time frame: From start to end of procedure
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
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
(SAEs) Serious Adverse events Rate
Time frame: 6, 12 and 24 months
Procedure-related Adverse events Rate
Time frame: 6, 12 and 24 months
(ADEs) Adverse device effects Rate
Time frame: 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lichtenberg, Dr. med. study director
Klinikum Hochsauerland GmbH
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Straub Medical AG at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Czechia, Estonia, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major adverse events (MAE) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.