Clinical trial NCT05444660: PMCF Study for Peripheral Arteries Below the Knee (BTK)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: FCRE (Foundation for Cardiovascular Research and Education)
First posted: 2022-07-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 Cordis US Corp.

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.

Eligibility criteria: Inclusion Criteria:

1. Patient is \>18 years old.
2. Target Lesion is located in the infrapopliteal arteries.
3. 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs
timeFrame: 30 days post procedure
measure: Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs
timeFrame: 30 days post procedure
measure: Technical success rate
timeFrame: during surgery
measure: Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Technical success rate
timeFrame: during surgery
measure: Technical success rate
timeFrame: during surgery up to 24 hours after surgery
measure: Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)
timeFrame: 30 days post-procedure
measure: Change of ABI Index
timeFrame: 30 days post-procedure
measure: Time-to-hemostasis (HTC)
timeFrame: up to 24 hours after surgery
measure: Time-to-ambulation
timeFrame: up to 24 hours after surgery
measure: Rate of Major Amputation free survival
timeFrame: 30 days post-procedure
measure: Clinical success
timeFrame: 30 days post-procedure
measure: Number of Participants without Vessel perforation/dissection
timeFrame: during surgery
measure: Freedom from Serious Adverse Events
timeFrame: 30 days post-procedure
measure: All cause of death
timeFrame: Through study completion
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Tirol Kliniken GmbH
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Wien
country: Austria
facility: Medizinische Universität
city: Freudenstadt
country: Germany
facility: Krankenhäuser Landkreis Freudenstadt gGmbH
city: Langensteinbach
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach GmbH
Study officials:
References: