PMCF Study for Peripheral Arteries Below the Knee (BTK)

Completed

• Conditions: Peripheral Artery Disease

• Registration Number: NCT05444660
• Lead Sponsor: Cordis Corporation

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.

Study Timeline

• Study First Submitted: 2022-04-14
• Study Start: 2022-05-05
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-06
• Primary Completion: 2022-09-09
• Study Completion: 2022-11-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs	30 days post procedure	Primary Safety Endpoint; Freedom from device and procedure related death.
Technical success rate	during surgery	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.
Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)	30 days post procedure	Primary Efficacy Endpoint; The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR)

Secondary Outcome Measures

Name	Time	Method
Change of ABI Index	30 days post-procedure	Secondary Performance Endpoint; Change of Ankle Brachial Index (ABI), compared to baseline ABI
Number of Participants without Freedom from clinically-driven target lesion revascularization (CD-TLR)	30 days post-procedure	Secondary Performance Endpoint; Freedom from clinically-driven target lesion revascularization (CD-TLR), defined as any reintervention at the target lesion due to symptoms
Number of Participants without Vessel perforation/dissection	during surgery	Secondary Safety Endpoint; Vessel perforation/dissection
Clinical success	30 days post-procedure	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)
Technical success rate	during surgery up to 24 hours after surgery	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)
All cause of death	Through study completion	Secondary Safety Endpoint; All cause of death
Time-to-hemostasis (HTC)	up to 24 hours after surgery	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.
Time-to-ambulation	up to 24 hours after surgery	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
Rate of Major Amputation free survival	30 days post-procedure	Secondary Safety Endpoint; Rate of Major Amputation free survival defined as any amputation below the knee
Freedom from Serious Adverse Events	30 days post-procedure	Secondary Safety Endpoint; Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)

Trial Locations

Locations (5)

Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt am Wörthersee, Austria

Medizinische Universität; 🇦🇹 Wien, Austria

SRH Klinikum Karlsbad-Langensteinbach GmbH; 🇩🇪 Langensteinbach, Germany

Krankenhäuser Landkreis Freudenstadt gGmbH; 🇩🇪 Freudenstadt, Germany

Tirol Kliniken GmbH; 🇦🇹 Innsbruck, Austria