STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions

Обзор

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.

Вмешательства

• Устройство Paclitaxel Coated Peripheral Angioplasty Balloon Catheter
  Paclitaxel 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

Первичные конечные точки

• Safety - MAEs at 12 months [Срок оценки: 12 months]
• Efficacy-PAK DCB Success at 12 months, defined as primary patency (PP) [Срок оценки: 12 months]
• 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: [Срок оценки: 12 Month]

Вторичные конечные точки (12)

• Technical success rate. [Срок оценки: During procedure]
• Device success defined. [Срок оценки: During procedure]
• Procedural success. [Срок оценки: Up to 3 days after index procedure]
• Rate of CDBOS. [Срок оценки: Up to 3 days after index procedure]
• Primary Patency at 12 months. [Срок оценки: 12 months]
• Secondary Patency at 12 months. [Срок оценки: 12 months]
• Freedom from clinically driven TLR at 30-day follow-up. [Срок оценки: 30 days]
• Freedom from clinically driven TLR at 6-month follow-up. [Срок оценки: 6 months]
• Freedom from clinically driven TLR at 12-month follow-up. [Срок оценки: 12 months]
• Freedom from TVR at 30-day follow-up. [Срок оценки: 30 days]
• Freedom from TVR at 6-month follow-up. [Срок оценки: 6 months]
• Freedom from TVR at 12-month follow-up. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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).
• Target Lesion >60% stenosis in the SFA or PA (based on angio-CT and/or confirmed in angiography).
• Target Lesion <150 mm that consists of no more than two adjacent lesions ≤ 25mm apart and is able to be completely covered with inflation of single investigated PAK DCB (with minimum of >5mm proximal and distal margin.

Note: Adjacent or tandem lesions must be treated as a single lesion.

• Reference Vessel Diameter (RVD) between 4.0 and 8.0mm and within treatment range of PAK® DCB to be used 1:1 at the target lesion.
• Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant ≥50% angiographic stenosis from origin to ankle.
• In-flow vessel (both iliac and femoral) without significant ≥50% angiographic stenosis or successful treatment (≤30% residual stenosis with no complications) of a diseased in-flow vessel at least 30 days prior to the index procedure.

Note: treatment of contralateral iliac arteries is allowed.

Критерии исключения

• 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.
• Active inflammatory process at the site of the planned puncture.
• Acute lower limb ischemia.
• Non-atherosclerotic lesion (e.g. vasculitis, dysplasia).
• Necessary concurrent non-target lesion interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or treatment with any other drug coated balloon.
• Massive calcifications of the treated lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends >50 continuous mm in length; reflective 3 or 4 on the PACSS scale https://doi.org/10.1002%2Fccd.25387).
• Angiographically confirmed presence of a thrombus in the target lesion.
• The target lesion requiring primary stenting.
• Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment.
• Previous bypass graft or stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath Note: In-stent restenosis is not allowed.
• Gastrointestinal or any other major bleeding in the past three months.
• Known bleeding disorder or uncontrolled hypercoagulable disorder.
• Myocardial infarction or any stroke within 30 days prior to the procedure.
• Known intolerance to required medications (especially antiplatelets and heparin), contrast media (that cannot be adequately pre-medicated), nitinol or paclitaxel.
• Pregnant and childbearing age women not using effective contraception.
• Participation in another investigational study (before completing primary endpoint analysis) or previous enrollment to this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 2 центра

• Department of Vascular Surgery; Malopolska Cardiovascular Center; Polish-American Heart Cl — Chrzanów
• University Hospital Clinical Hospital No. 2 PUM in Szczecin, Department of General, Dental — Szczecin

Испания · 1 центр

• Vascular Surgery Teaching Unit CardioVascular Institute Hospital Clinic University of Barc — Barcelona

Публикации

• Buszman PP, Nowakowski P, Milewski K, Orlik B, Zurakowski A, Ludyga T, Polczyk F, Debinski M, Jelonek M, Kachel M, Gasior M, Granada JF, Kiesz RS, Buszman PE. Clinical Randomized Trial Evaluating Novel, Microcrystalline, and Biocompatible Polymer Paclitaxel-Coated Balloon for the Treatment of Femoropopliteal Occlusive Disease: The BIOPAC Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2436-2438. PMID 30522679

Идентификаторы

NCT: NCT06734221 · 24-BAL-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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