Popliteal Artery Stenosis Above the KneeSTAR-PAKNCT06734221
STAR-PAK Study: Evaluating the Safety and Efficacy of PAK® (Paclitaxel Coated Balloon) in Treating Atherosclerotic Femoro-Popliteal Lesions
A study testing Paclitaxel Coated Peripheral Angioplasty Balloon Catheter in people with Popliteal Artery Stenosis Above the Knee and Peripheral Artery Disease, run by Balton Sp.zo.o. at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Popliteal Artery Stenosis Above the Knee, Peripheral Artery Disease, Superficial Femoral Artery Stenosis
- What is being tested?
- Paclitaxel Coated Peripheral Angioplasty Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Sep 2024to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Poland2 sites, 2 recruiting
- Recruiting
Department of Vascular Surgery; Malopolska Cardiovascular Center; Polish-American Heart Clinics
Chrzanów, Malopolska, 32-500
Przemysław Nowakowski, Prof., (+48) 32 758 69 19, nowakowski.mcsn@gmail.com
- Recruiting
University Hospital Clinical Hospital No. 2 PUM in Szczecin, Department of General, Dental and Interventional Radiology
Szczecin, West Pomeranian Voivodeship, 70-111
Aleksander Falkowski, Prof., (+48) 603945465, bakhis@hot.pl
Spain1 site, 1 recruiting
- Not yet recruiting
Vascular Surgery Teaching Unit CardioVascular Institute Hospital Clinic University of Barcelona
Barcelona, Barcelona, 08036
Vincent Riambau, MD, PhD, (+34) 607958090, vriambau@clinic.cat
About this study
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.
Read more
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
- Popliteal Artery Stenosis Above the Knee, Peripheral Artery Disease, Superficial Femoral Artery Stenosis
- Being tested
- Paclitaxel Coated Peripheral Angioplasty Balloon Catheter
- Keywords
- Peripheral Artery Disease, Drug Coated Balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Coated Peripheral Angioplasty Balloon CatheterDevice
Also called PAK®
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.
| Study group | Role | What they receive |
|---|---|---|
| PAK DCB catheter | Experimental | Peripheral revascularization procedure using a PAK DCB catheter covered with paclitaxel. Receives: Device: Paclitaxel Coated Peripheral Angioplasty Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 12 Month
Secondary outcomes (21)
Technical success rate.
Technical success rate defined as successful balloon insertion, balloon inflation and removal.
Measured: 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).
Measured: During procedure
Procedural success.
Procedural success defined as device success with no major complications. (death, myocardial infarction, amputation, stroke).
Measured: Up to 3 days after index procedure
Rate of CDBOS.
Rate of Clinically Driven Bail-Out Stenting
Measured: 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.
Measured: 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.
Measured: 12 months
Freedom from clinically driven TLR at 30-day follow-up.
Measured: 30 days
Freedom from clinically driven TLR at 6-month follow-up.
Measured: 6 months
Freedom from clinically driven TLR at 12-month follow-up.
Measured: 12 months
Freedom from TVR at 30-day follow-up.
Measured: 30 days
Freedom from TVR at 6-month follow-up.
Measured: 6 months
Freedom from TVR at 12-month follow-up.
Measured: 12 months
All-cause mortality at 30-day follow-up.
Measured: 30 days
All-cause mortality at 6-month follow-up.
Measured: 6 months
All-cause mortality at 12-month follow-up.
Measured: 12 months
Major amputation rate at 30-day follow-up.
Measured: 30 days
Major amputation rate at 6-month follow-up.
Measured: 6 months
Major amputation rate at 12-month follow-up.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start15 Sep 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Popliteal Artery Stenosis Above the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balton Sp.zo.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734221
- Sponsor's protocol ID
- 24-BAL-0001
- Acronym
- STAR-PAK
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30522679
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- STAR-PAK / 24-BAL-0001
- Conditions
- Popliteal Artery Stenosis Above the Knee, Peripheral Artery Disease, Superficial Femoral Artery Stenosis
- Keywords
- Peripheral Artery Disease, Drug Coated Balloon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Balton Sp.zo.o.Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAK DCB catheter | Experimental | Device: Paclitaxel Coated Peripheral Angioplasty Balloon CatheterPeripheral revascularization procedure using a PAK DCB catheter covered with paclitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel Coated Peripheral Angioplasty Balloon CatheterAlso: PAK®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. | Device | PAK DCB catheter |
Primary outcome
Safety - MAEs at 12 months
Time frame: 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.
Efficacy-PAK DCB Success at 12 months, defined as primary patency (PP)
Time frame: 12 months
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.
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:
Time frame: 12 Month
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%.
21 secondary outcomes
Technical success rate.
Time frame: During procedure
Device success defined.
Time frame: During procedure
Procedural success.
Time frame: Up to 3 days after index procedure
Rate of CDBOS.
Time frame: Up to 3 days after index procedure
Primary Patency at 12 months.
Time frame: 12 months
Secondary Patency at 12 months.
Time frame: 12 months
Freedom from clinically driven TLR at 30-day follow-up.
Time frame: 30 days
Freedom from clinically driven TLR at 6-month follow-up.
Time frame: 6 months
Freedom from clinically driven TLR at 12-month follow-up.
Time frame: 12 months
Freedom from TVR at 30-day follow-up.
Time frame: 30 days
Freedom from TVR at 6-month follow-up.
Time frame: 6 months
Freedom from TVR at 12-month follow-up.
Time frame: 12 months
All-cause mortality at 30-day follow-up.
Time frame: 30 days
All-cause mortality at 6-month follow-up.
Time frame: 6 months
All-cause mortality at 12-month follow-up.
Time frame: 12 months
Major amputation rate at 30-day follow-up.
Time frame: 30 days
Major amputation rate at 6-month follow-up.
Time frame: 6 months
Major amputation rate at 12-month follow-up.
Time frame: 12 months
Clinical improvement at 30-day follow-up.
Time frame: 30 days
Clinical improvement at 6-month follow-up.
Time frame: 6 months
Clinical improvement at 12-month follow-up.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 30522679Buszman 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Coated Peripheral Angioplasty Balloon Catheter in people with Popliteal Artery Stenosis Above the Knee and Peripheral Artery Disease, run by Balton Sp.zo.o. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elżbieta Sojka ((+48) 22 597 44 43, elzbieta.sojka@balton.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - MAEs at 12 months (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.