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.

PMCF Study for Peripheral Arteries Below the Knee (BTK)

Peripheral Artery Disease

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.

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.

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

Primary Safety Endpoint

Freedom from device and procedure related death.

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.

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

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.

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)

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

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

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.

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

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

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)

Secondary Safety Endpoint

Vessel perforation/dissection

Secondary Safety Endpoint

Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)

PMCF Study for Peripheral Arteries Below the Knee (BTK)

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status