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Tests treatment safety and results for Popliteal Artery Stenosis Above the Knee
Official title STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions
ClinicalTrials.gov ID: NCT06734221
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Target Lesion \>60% stenosis in the SFA or PA (based on angio-CT and/or confirmed in angiography).
You likely can't join if
- Life expectancy less than 2 years.
- Suspected or detected malignancy without completed treatment (not considered cured).
- Planned surgical or treatment 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.
See the full eligibility 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 \ 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...
- Life expectancy less than 2 years.
- Suspected or detected malignancy without completed treatment (not considered cured).
- Planned surgical or treatment 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chrzanów, Malopolska, Poland
- Szczecin, West Pomeranian Voivodeship, Poland
- Barcelona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chrzanów, Malopolska, Poland; Szczecin, West Pomeranian Voivodeship, Poland; Barcelona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.