The primary objective of the study is to evaluate the performance and the safety of the PAK® DCB Catheter in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and/or popliteal arteries (SFA/PA) of patients with symptomatic peripheral artery disease (PAD).
The study enrolls patients who have been diagnosed with peripheral artery disease with stenosis of the superficial femoral or popliteal artery and are qualified for endovascular revascularization.
Lower extremity peripheral artery disease may be asymptomatic or may be accompanied by clinical symptoms due to restricted blood flow to the lower extremities.
The management of a patient diagnosed with peripheral arteriosclerosis is primarily aimed at reducing symptoms of limb ischemia and improving blood supply to the limb, as well as seeking to halt the progression of the disease.
Treatment of lower extremity atherosclerosis with percutaneous methods is a well-known minimally invasive and recommended treatment for lower extremity ischemia.
A maximum of 120 patients will be included in the study. All patients included in the study will receive treatment with the investigational device.
The study will use the PAK balloon catheter, which is CE certified and approved for the treatment of patients with peripheral vascular disease. That is, it is also used as standard outside the study. The test procedure with the study device is in accordance with its registration and instructions for use.
Age ≥ 18 years.
Written informed consent of the patient to participate in the study.
Symptoms of lower limb ischemia defined by Rutherford classification from 2 to 4.
At least one de novo or restenotic lesion, in SFA and/or PA defined as a lesion with a proximal origin >10mm from SFA origin and a distal end above the knee joint (at least 3 cm above bottom of the femur- P1).
Life expectancy less than 2 years.
Suspected or detected malignancy without completed treatment (not considered cured).
Planned surgical or interventional procedures within 30 days after the study procedure.
Known impaired renal function with GFR ≤30 mL/min per 1.73 m2 and/or elevated serum creatinine > 2.5mg/dL or on dialysis.
Single group
Paclitaxel Coated Peripheral Angioplasty Balloon Catheter
DevicePaclitaxel coated peripheral angioplasty balloon catheters are catheters of "over the wire" (OTW) type. Distal part of the catheter consists of two channels. External channel is used for inflating the balloon, and internal channel is the guide wire. Catheter has two markers enabling precise determination of balloon position in the vessel. The balloon is covered with a coating POLIGRADE® and drug paclitaxel an amount to 2.5 µg/mm2 , which is eluting during balloon inflation. Paclitaxel belongs to alkaloids group from taxanes group. It is cytostatic and it inhibits the cell cycle in G2/M phase. By inhibiting division of cells and their migration, paclitaxel allows for limiting restenosis phenomenon. Paclitaxel selectively inhibits smooth myocytes proliferation, while the endothelium cells show higher resistance to its action. In addition, paclitaxel restricts inflammatory conditions in walls of the arteries after balloon angioplasty.
Safety - MAEs at 12 months
Major Adverse Events (MAEs) at 12 months defined as the composite of: target-limb-related death, major amputation of the target limb and, re-intervention of the target limb.
Efficacy-PAK DCB Success at 12 months, defined as primary patency (PP)
PAK DCB Success at 12 months, defined as primary patency (PP) in the absence of clinically driven bail-out stenting (CDBOS), as defined below. Subjects with no CDBOS will be assessed for PP for the purposes of determining True DCB Success. Clinically Driven Bail-Out Stenting (CDBOS): Stents are considered clinically driven when the angiographic core lab determines that a stent was placed after DCB use during the index procedure under the following conditions that were not resolved by prolonged balloon inflation: •Unresolved flow limiting dissection (Type E or F), OR •Residual lumen diameter stenosis \> 50% A subject with a CDBOS fails the True DCB success endpoint regardless of patency outcomes.
Primary Patency: Subjects who will achieve primary patency by a combination of duplex ultrasound review and no evidence of clinically driven target lesion revascularization (CD-TLR) prior to the study required 12-month DUS as defined below:
Duplex Ultrasound Review: A patent target lesion shows a Peak Systolic Velocity Ratio (PSVR) less than 2.5 by the Duplex Ultrasound DUS core lab or Clinically Driven Target Lesion Revascularization CD-TLR: any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed that was considered clinically driven when both of the following conditions were met: Worsening clinical based on an ankle-brachial index (ABI) decrease≥20%or\>0.15 compared to maximum early postprocedure ABI or documented increase in Rutherford by at least one class if ABI change was unattainable. Angiographic core lab adjudication of the revascularization angiogram confirming that the target lesion prior to re-intervention demonstrated diameter stenosis \>50%.
Technical success rate.
Technical success rate defined as successful balloon insertion, balloon inflation and removal.
Device success defined.
Device success defined as ability to achieve optimal percutaneoustransluminal angioplasty (PTA) outcome (≤30% residual diameter stenosis in post-procedural angiography with no flow-limiting dissection at the target lesion).
Procedural success.
Procedural success defined as device success with no major complications. (death, myocardial infarction, amputation, stroke).
Rate of CDBOS.
Rate of Clinically Driven Bail-Out Stenting
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Balton Sp.zo.o.
Lead sponsor
KCRI
Collaborator
