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Peripheral Artery DiseaseNCT05444660

PMCF Study for Peripheral Arteries Below the Knee (BTK)

An observational study of Peripheral Artery Disease, run by Cordis US Corp. at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC) of the infra-popliteal vessels, using at least one of the products (named above) from… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease
How many people
102 participants
Where
5 sitesin 2 countries
Study dates
5 May 2022to 2 Nov 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: Diseased patients with PAD who underwent an endovascular intervention within standard-of-care (SOC) of the infra-popliteal vessels. In this PMCF study, data from minimally invasive medical devices will be collected. Indications for which the study devices are intended are listed in section 3.1. Patient's data will be selected based on the investigator's assessment and evaluation of the underlying disease. The patient's medical condition should have been stable, with no underlying medical condition which would prevent them from undergoing the required endovascular intervention at the time of procedure. The total sample size for this PMCF study is 100 patients, divided over up to 10 sites, throughout an enrolment period of 6 months.

Who may be able to join

  • Patient is >18 years old.
  • Target Lesion is located in the infrapopliteal arteries.
  • Patient who underwent treatment (PTA) in the infrapopliteal vessels with at least one of the SABER OTW PTA Catheter the SABERX PTA Catheter and/or the Powerflex Pro PTA Catheter as described in the IFU for each device.

Who cannot join

  • Anatomy or size of vessels that would have not allowed appropriate usage of the study devices, following IFU of the study devices.
  • Patients who were not suitable for receiving interventional surgeries of lower limb arteries for treatment.
  • Women who were pregnant or lactating at time of the procedure.
  • Any patient who was considered to be hemodynamically unstable at onset of procedure.
  • Patient was not available for follow up at the clinical site.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Austria3 sites

  • Tirol Kliniken GmbH

    Innsbruck

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

  • Medizinische Universität

    Vienna

Other trials in Austria

Germany2 sites

  • Krankenhäuser Landkreis Freudenstadt gGmbH

    Freudenstadt, 72250

  • SRH Klinikum Karlsbad-Langensteinbach GmbH

    Langensteinbach, 76307

Other trials in Germany

About this study

Official title: A Retrospective Post Market Clinical Follow-up (PMCF) Study Evaluating the Safety and Clinical Performance of the SABER (OTW) PTA Dilatation Catheter, SABERX PTA Dilatation Catheter, and Powerflex Pro PTA Catheter Used in Infra-popliteal Vessels, During Percutaneous Transluminal Angioplasty (PTA) Procedures.

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC) of the infra-popliteal vessels, using at least one of the products (named above) from Cordis US Corp.

Read the detailed description

Peripheral artery disease can be a severe and complex condition that is still a challenge for both surgical and endovascular therapies (1,2). Arterial disease is known to be located predominantly in the superficial femoral artery in patients with claudication and in the below-the-knee (BTK) region in patients with critical limb ischemia (CLI). Especially in patients with diabetes (3-5), -where arterial disease is commonly characterized by long, multilevel disease involving all infrapopliteal vessels-the risk of peripheral artery disease is significantly higher and tends to be more aggressive than in patients without diabetes.

Infrapopliteal arterial occlusive disease afflicts numerous patients with pain at rest, ischemic ulceration, or gangrene (6-7). Critical limb ischemia (CLI) mainly results from this disease. In general, patients suffering from CLI have many comorbidities, such as diabetes mellitus and end-stage renal disease, and often have high morbidity, mortality, and consumption of health care and social care resources (6). Therefore, effectual management is urgently required for patients with CLI.

With the rapid improvements in endovascular instruments and experience of physicians, endovascular therapy has become a major option for the revascularization of infrapopliteal occlusive arteries. Percutaneous transluminal angioplasty (PTA) is the most commonly used endovascular therapy for this disease, especially during the initial onset of CLI. Currently, PTA is considered an effective treatment because of its minimal invasiveness, shortened hospitalization time, and acceptable patency rate (8-9). In recent years, several studies have assessed the safety and efficacy of PTA.

In this regard, the purpose of the current post market clinical follow-up (PMCF) trial is to assess the safety and efficacy of different CE-marked medical devices from Cordis (SABER OTW PTA Dilatation Catheter, SABERX PTA Dilatation Catheter, and Powerflex Pro PTA Catheter) used in the infrapopliteal vessels BTK, when used as intended by the manufacturer (i.e., adhering to the Instruction for Use - IFU). The devices under investigation in the current study are the SABER OTW PTA Dilatation Catheter, SABERX PTA Dilatation Catheter, and Powerflex Pro PTA Catheter, which are described in detail in section 3.1.

Also, data will be collected which may also include acute outcomes for the additional supportive devices listed below in detail in section 4. that may have been used during peripheral angioplasty procedure. However, these devices are not a part of the study devices and would not affect the inclusion criteria for study. The additional devices include the Cordis guidewires (Emerald, ATW, Stablizer, Storq, SV 0.018", Wizdom), Cordis guiding catheters (Adroit, Vista Brite Tip), Cordis diagnostic catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F/5F/6F, Tempo 4F, Tempo Aqua, High Flow, Pigtail Straightener), Cordis vascular access devices (Avanti+, Brite Tip, Vista Brite IG, vessel dilator), Cordis vascular closure devices (MynxGrip and Mynx Control) and Cordis OUTBACK CTO catheters which may be used during peripheral angioplasty procedures.

Medical subject headings
Peripheral Arterial Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

    Primary Safety Endpoint

    Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs)

    Measured: 30 days post procedure

  2. Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs

    Primary Safety Endpoint

    Freedom from device and procedure related death.

    Measured: 30 days post procedure

  3. Technical success rate

    Technical success rate defined as successful crossing, introduction, deflation and a <30% residual stenosis on visual assessment of the SABER OTW PTA Catheter, SABERX PTA Catheter, and/or the Powerflex Pro PTA Catheter according to the respective IFU.

    Measured: during surgery

  4. Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)

    Primary Efficacy Endpoint

    The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR)

    Measured: 30 days post procedure

Secondary outcomes (11)

  1. Technical success rate

    Secondary Performance Endpoint

    Technical success rate defined as successful crossing, introduction, deployment and successful completion of the procedure of the Cordis guidewires (Emerald, ATW, Stablizer, Storq, SV 0.018", Wizdom) and/or the Cordis guiding catheters (Adroit, Vista Brite Tip) and/or the Cordis diagnostic catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F/5F/6F, Tempo 4F, Tempo Aqua, High Flow, Pigtail Straightener) and/or the Cordis vascular access devices (Avanti+, Brite Tip, Vista Brite IG, vessel dilator) and/or the Cordis vascular closure devices (MynxGrip and Mynx Control) and/or the Cordis OUTBACK CTO catheters according to the respective IFU.

    Measured: during surgery

  2. Technical success rate

    Secondary Performance Endpoint

    Technical success rate defined as successful hemostasis without conversion to manual/mechanical compression of the Cordis vascular closure devices (MynxGrip and Mynx Control)

    Measured: during surgery up to 24 hours after surgery

  3. Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)

    Secondary Performance Endpoint

    Freedom from clinically-driven target lesion revascularization (CD-TLR), defined as any reintervention at the target lesion due to symptoms

    Measured: 30 days post-procedure

  4. Change of ABI Index

    Secondary Performance Endpoint

    Change of Ankle Brachial Index (ABI), compared to baseline ABI

    Measured: 30 days post-procedure

  5. Time-to-hemostasis (HTC)

    Secondary Performance Endpoint

    Time-to-hemostasis assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control). Categorized as Hemostatic time category (HTC) ≤2, HTC >2 to ≤4, HTC >4 to ≤5, HTC >5 to ≤7, HTC >7 to ≤10 min.

    Measured: up to 24 hours after surgery

  6. Time-to-ambulation

    Secondary Performance Endpoint

    Time-to-ambulation assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control) defined as time between end of the procedure and ambulation in hours

    Measured: up to 24 hours after surgery

  7. Rate of Major Amputation free survival

    Secondary Safety Endpoint

    Rate of Major Amputation free survival defined as any amputation below the knee

    Measured: 30 days post-procedure

  8. Clinical success

    Secondary Safety Endpoint

    Clinical success, defined as an improvement of the Rutherford Classification of one class or more, as compared to the baseline Rutherford Classification (Rutherford Classification category from 0 to 6)

    Measured: 30 days post-procedure

  9. Number of Participants without Vessel perforation/dissection

    Secondary Safety Endpoint

    Vessel perforation/dissection

    Measured: during surgery

  10. Freedom from Serious Adverse Events

    Secondary Safety Endpoint

    Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)

    Measured: 30 days post-procedure

  11. All cause of death

    Secondary Safety Endpoint

    All cause of death

    Measured: Through study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start5 May 2022
  3. Primary completion9 Sep 2022
  4. Study completion2 Nov 2022

Resources

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
Other
Time perspective
Retrospective
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444660
Sponsor's protocol ID
FCRE 220104
Status last verified
Jul 2023
First submitted
14 Apr 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Artery Disease, run by Cordis US Corp. at 5 sites in 2 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 3 inclusion and 5 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Austria, Germany. 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?

Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs (time frame: 30 days post procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444660.

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 27 Jul 2023.

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