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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease; Superficial Femoral Artery Stenosis; Popliteal Artery Stenosis Above the Knee
• Intervention / Treatment: Device: Paclitaxel Coated Peripheral Angioplasty Balloon Catheter

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elżbieta Sojka; Phone Number: (+48) 22 597 44 43; Email: elzbieta.sojka@balton.pl

Study Locations

• Poland
  • Malopolska
    • Chrzanów, Malopolska, Poland, 32-500
      • Recruiting
      • Department of Vascular Surgery; Malopolska Cardiovascular Center; Polish-American Heart Clinics
      • Contact: Przemysław Nowakowski, Prof.; Phone Number: (+48) 32 758 69 19; Email: nowakowski.mcsn@gmail.com
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 70-111
      • Recruiting
      • University Hospital Clinical Hospital No. 2 PUM in Szczecin, Department of General, Dental and Interventional Radiology
      • Contact: Aleksander Falkowski, Prof.; Phone Number: (+48) 603945465; Email: bakhis@hot.pl
• Spain
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Vascular Surgery Teaching Unit CardioVascular Institute Hospital Clinic University of Barcelona
    • Contact: Vincent Riambau, MD, PhD; Phone Number: (+34) 607958090; Email: vriambau@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Written informed consent of the patient to participate in the study.
3. Symptoms of lower limb ischemia defined by Rutherford classification from 2 to 4.
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).
5. Target Lesion >60% stenosis in the SFA or PA (based on angio-CT and/or confirmed in angiography).

6. 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.

7. 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.
8. 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.
9. 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.

Exclusion Criteria:

1. Life expectancy less than 2 years.
2. Suspected or detected malignancy without completed treatment (not considered cured).
3. Planned surgical or interventional procedures within 30 days after the study procedure.
4. Known impaired renal function with GFR ≤30 mL/min per 1.73 m2 and/or elevated serum creatinine > 2.5mg/dL or on dialysis.
5. Active inflammatory process at the site of the planned puncture.
6. Acute lower limb ischemia.
7. Non-atherosclerotic lesion (e.g. vasculitis, dysplasia).
8. 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.
9. 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).
10. Angiographically confirmed presence of a thrombus in the target lesion.
11. The target lesion requiring primary stenting.
12. Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment.
13. 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.
14. Gastrointestinal or any other major bleeding in the past three months.
15. Known bleeding disorder or uncontrolled hypercoagulable disorder.
16. Myocardial infarction or any stroke within 30 days prior to the procedure.
17. Known intolerance to required medications (especially antiplatelets and heparin), contrast media (that cannot be adequately pre-medicated), nitinol or paclitaxel.
18. Pregnant and childbearing age women not using effective contraception.
19. Participation in another investigational study (before completing primary endpoint analysis) or previous enrollment to this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PAK DCB catheter; Peripheral revascularization procedure using a PAK DCB catheter covered with paclitaxel.

Device: 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 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.; Other Names: PAK®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	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:	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%.	12 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate.	Technical success rate defined as successful balloon insertion, balloon inflation and removal.	During procedure
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).	During procedure
Procedural success.	Procedural success defined as device success with no major complications. (death, myocardial infarction, amputation, stroke).	Up to 3 days after index procedure
Rate of CDBOS.	Rate of Clinically Driven Bail-Out Stenting	Up to 3 days after index procedure
Primary Patency at 12 months.	Primary Patency at 12 months, defined as target lesion restenosis as determined by DUS (PSVR < 2.5) and freedom from CD-TLR.	12 months
Secondary Patency at 12 months.	Secondary Patency at 12 months defined by a PSVR less than 2.5 on DUS regardless of the need for TLR.	12 months
Freedom from clinically driven TLR at 30-day follow-up.		30 days
Freedom from clinically driven TLR at 6-month follow-up.		6 months
Freedom from clinically driven TLR at 12-month follow-up.		12 months
Freedom from TVR at 30-day follow-up.		30 days
Freedom from TVR at 6-month follow-up.		6 months
Freedom from TVR at 12-month follow-up.		12 months
All-cause mortality at 30-day follow-up.		30 days
All-cause mortality at 6-month follow-up.		6 months
All-cause mortality at 12-month follow-up.		12 months
Major amputation rate at 30-day follow-up.		30 days
Major amputation rate at 6-month follow-up.		6 months
Major amputation rate at 12-month follow-up.		12 months
Clinical improvement at 30-day follow-up.	Clinical improvement at 30-day follow-up compared to the baseline, defined by Rutherford classification improved by at least one category if ABI improved by at least 20% or 0.15.	30 days
Clinical improvement at 6-month follow-up.	Clinical improvement at 6-month follow-up compared to the baseline, defined by Rutherford classification improved by at least one category if ABI improved by at least 20% or 0.15.	6 months
Clinical improvement at 12-month follow-up.	Clinical improvement at 12-month follow-up compared to the baseline, defined by Rutherford classification improved by at least one category if ABI improved by at least 20% or 0.15.	12 months

Collaborators and Investigators

• Sponsor: Balton Sp.zo.o.
• Collaborators: KCRI

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.jcin.2018.07.029. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Drug Coated Balloon
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Constriction, Pathologic; Peripheral Arterial Disease; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 24-BAL-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No