PMCF Study for Peripheral Arteries Below the Knee (BTK)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease

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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Tirol Kliniken GmbH
  • Klagenfurt am Wörthersee, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee
  • Wien, Austria
    • Medizinische Universitat
• Germany
  • Freudenstadt, Germany, 72250
    • Krankenhäuser Landkreis Freudenstadt gGmbH
  • Langensteinbach, Germany, 76307
    • SRH Klinikum Karlsbad-Langensteinbach GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days post procedure
Number of Patients without Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs	Primary Safety Endpoint Freedom from device and procedure related death.	30 days post procedure
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.	during surgery
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)	30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during surgery
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)	during surgery up to 24 hours after surgery
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	30 days post-procedure
Change of ABI Index	Secondary Performance Endpoint Change of Ankle Brachial Index (ABI), compared to baseline ABI	30 days post-procedure
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.	up to 24 hours after surgery
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	up to 24 hours after surgery
Rate of Major Amputation free survival	Secondary Safety Endpoint Rate of Major Amputation free survival defined as any amputation below the knee	30 days post-procedure
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)	30 days post-procedure
Number of Participants without Vessel perforation/dissection	Secondary Safety Endpoint Vessel perforation/dissection	during surgery
Freedom from Serious Adverse Events	Secondary Safety Endpoint Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)	30 days post-procedure
All cause of death	Secondary Safety Endpoint All cause of death	Through study completion

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Collaborators: FCRE (Foundation for Cardiovascular Research and Education)

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: FCRE 220104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No