Actively Recruiting
STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions
Led by Balton Sp.zo.o. · Updated on 2024-12-16
120
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Balton Sp.zo.o.
Lead Sponsor
K
KCRI
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Written informed consent to participate in the study
- Symptoms of lower limb ischemia classified as Rutherford 2 to 4
- At least one new or recurrent lesion in the superficial femoral or popliteal artery located more than 10 mm from the SFA origin and above the knee joint
- Target lesion with more than 60% stenosis confirmed by angiography or angio-CT
- Target lesion less than 150 mm in length, consisting of no more than two adjacent lesions 25 mm apart or less, treatable with a single PAK DCB with at least 5 mm margin
- Reference vessel diameter between 4.0 and 8.0 mm
- At least one patent tibial vessel with less than 50% stenosis from origin to ankle
- In-flow vessels (iliac and femoral) with less than 50% stenosis or successfully treated at least 30 days before the procedure
You will not qualify if you...
- Life expectancy less than 2 years
- Suspected or untreated malignancy
- Planned surgery or intervention within 30 days after the study procedure
- Impaired kidney function with GFR 30 mL/min/1.73 m2 or lower, creatinine over 2.5 mg/dL, or dialysis
- Active inflammation at puncture site
- Acute lower limb ischemia
- Non-atherosclerotic lesions such as vasculitis or dysplasia
- Concurrent non-target lesion interventions like atherectomy, laser, drug-eluting stent, or other drug-coated balloons
- Massive calcifications of the treated lesion
- Blood clots confirmed in the target lesion
- Target lesion requiring primary stenting
- Vessel perforation, severe dissection, or injury at enrollment
- Previous bypass graft or stent near target lesion or iliac stent preventing balloon passage
- Major bleeding in last 3 months
- Known bleeding or uncontrolled clotting disorders
- Heart attack or stroke within 30 days prior
- Intolerance to required medications, contrast media, nitinol, or paclitaxel
- Pregnant or childbearing women not using effective contraception
- Participation in another investigational study before primary endpoint analysis or previous enrollment in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of Vascular Surgery; Malopolska Cardiovascular Center; Polish-American Heart Clinics
Chrzanów, Malopolska, Poland, 32-500
Actively Recruiting
2
University Hospital Clinical Hospital No. 2 PUM in Szczecin, Department of General, Dental and Interventional Radiology
Szczecin, West Pomeranian Voivodeship, Poland, 70-111
Actively Recruiting
3
Vascular Surgery Teaching Unit CardioVascular Institute Hospital Clinic University of Barcelona
Barcelona, Barcelona, Spain, 08036
Not Yet Recruiting
Research Team
E
Elżbieta Sojka
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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