STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treatin… (NCT06734221) | Clinical Trial Compass
RecruitingNot Applicable
STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions
Poland, Spain120 participantsStarted 2024-09-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety - MAEs at 12 months
Timeframe: 12 months
2
Efficacy-PAK DCB Success at 12 months, defined as primary patency (PP)
Timeframe: 12 months
3
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:
. 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.
Exclusion criteria
. 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.
. 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.