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Coronary Artery DiseaseNCT05946629

SELUTION 4 De Novo Small Vessel IDE Trial

A study testing PCI with SELUTION SLR DCB and PCI with FDA approved "-limus" DES in people with Coronary Artery Disease, run by M.A. Med Alliance S.A. at 70 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PCI with SELUTION SLR DCB and PCI with FDA approved "-limus" DES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
960 participants
Where
70 sitesin 3 countries
Study dates
20 Oct 2023to Sep 2031
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

  • Clinical Inclusion Criteria
  • Subjects must meet all of the following clinical criteria to participate in the trial:
  • Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
  • Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
  • Subject presents with chronic coronary syndromes [CCS] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.
  • Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).
Show all 21Show fewer
  • Subject has life expectancy > 1 year in the opinion of the investigator.
  • Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
  • PK Sub- Study Inclusion Criteria:
  • Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria:
  • 1. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations.
  • Imaging Inclusion Criteria
  • Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:
  • A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment > 30 days from the index procedure.
  • Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion.
  • Target lesion is ≤ 36 mm in length.
  • Target lesion has diameter stenosis > 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.
  • Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm [by visual assessment].
  • Target lesion is within a native coronary artery or major branch.
  • A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.
  • The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment.

Who cannot join

  • Clinical Exclusion Criteria
  • Subjects who meet any of the following clinical criteria will be excluded from the trial:
  • Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
  • Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
  • Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
  • Subject with planned major surgery within 30 days following the index procedure.
Show all 30Show fewer
  • Subject with planned treatment of lesion involving aorto-ostial location.
  • Subject with PCI of a non-target vessel within ± 30 days of the index procedure.
  • Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
  • Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).
  • Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
  • Subjects with current documented left ventricular ejection fraction (LVEF) < 30%.
  • Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
  • Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
  • Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.
  • Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate [GFR] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or had undergone renal transplantation.
  • PK Sub-Study Exclusion Criteria:
  • Subjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met:
  • Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure.
  • Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures >30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.
  • The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.
  • Subject is concurrently enrolled in the main protocol angiographic registry.
  • Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir.
  • Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.
  • Angiographic Exclusion Criteria
  • Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:
  • Target lesion is totally occluded or has evidence of thrombus.
  • Target lesion is located in the left main or any arterial or venous graft.
  • Target lesion is in a side branch that is "jailed" by a main vessel stent.
  • In stent restenosis

Trial locations and contacts

70 sites in 3 countries.

70 sites in 3 countries

United States65 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Hendrick Health

    Abilene, Texas, 79601

  • Atlanta VA

    Atlanta, Georgia, 30033

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Emory

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess

    Boston, Massachusetts, 02114

  • Mass General

    Boston, Massachusetts, 02114

  • Brigham & Women's

    Boston, Massachusetts, 02115

  • Manatee Memorial

    Bradenton, Florida, 34208

  • CAMC

    Charleston, West Virginia, 25304

  • CHI Memorial

    Chattanooga, Tennessee, 37404

  • University of Nebraska

    Chattanooga, Tennessee, 37404

  • CISD Sharp Chula Vista

    Chula Vista, California, 91911

  • The Lindner Research Center at Christ

    Cincinnati, Ohio, 45219

  • Mease Countryside Hospital

    Clearwater, Florida, 34695

  • UH Cleveland

    Cleveland, Ohio, 44120

  • Texas Health

    Dallas, Texas, 75231

  • Baylor Scott and White - Dallas

    Dallas, Texas, 75246

  • Hamilton Medical Center

    Dalton, Georgia, 30720

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • Englewood Health

    Englewood, New Jersey, 07631

  • Medical City of Fort Worth

    Fort Worth, Texas, 76104

  • Colorado Heart and Vascular

    Golden, Colorado, 80401

  • Penn State Health Hershey & Berks

    Hershey, Pennsylvania, 17033

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • University of Iowa Medical Center

    Iowa City, Iowa, 52242

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

  • St. Bernards

    Jonesboro, Arkansas, 72401

  • HCA Largo

    Largo, Florida, 33770

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Cedars Sinai

    Los Angeles, California, 90048

  • UPMC Pinnacle

    Mechanicsburg, Pennsylvania, 17050

  • Advocate Aurora St. Luke's

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Intermountain Health - Salt Lake City

    Murray, Utah, 84107

  • HCA Centennial

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Northwell Health Lenox Hill

    New York, New York, 10075

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Oklahoma Heart

    Oklahoma City, Oklahoma, 73120

  • University of Nebraska

    Omaha, Nebraska, 68198

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • HCA Overland Park

    Overland Park, Missouri, 66211

  • Baylor Scott and White Plano

    Plano, Texas, 75093

  • Lifespan Rhode Island & Miriam

    Providence, Rhode Island, 02903

  • NC Heart and Vascular

    Raleigh, North Carolina, 27607

  • HCA Chippenham

    Richmond, Virginia, 23225

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • HCA Northside

    St. Petersburg, Florida, 33709

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Baylor Scott and White - Temple

    Temple, Texas, 76508

  • Archbold Memorial Hospital

    Thomasville, Georgia, 31792

  • ClinRe

    Thornton, Colorado, 80023

  • HCA Los Robles

    Thousand Oaks, California, 91360

  • Harbor UCLA

    Torrance, California, 90502

  • HCA Trinity

    Trinity, Florida, 34655

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

  • WellSpan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Germany3 sites

  • Universitäts-Herzzentrum Freiburg

    Bad Krozingen, 79189

  • UKB Berlin

    Berlin, 12683

  • Herzzentrum Dresden

    Dresden, 01307

Other trials in Germany

Belgium2 sites

  • ZOL Genk

    Genk, 3600

  • Hartcentrum Hasselt Jessa Ziekenhuis

    Hasselt, 3500

Other trials in Belgium

About this study

Official title: A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.

The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Read the detailed description

Prospective, randomized controlled, single-blind, multicenter, clinical trial

The study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Subjects who present with chronic coronary syndrome (CCS), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) with an indication for percutaneous coronary intervention (PCI) with planned intervention for de novo lesions in small coronary vessels (RVD 2.00 mm to 2.75 mm) and meeting all eligibility criteria will be randomized 1:1 to treatment of the identified target lesion with either the SELUTION SLR 014 PTCA DEB or contemporary DES.

Randomized Cohort:

  • Intervention (DEB Strategy): Subjects randomized to the SELUTION SLR 014 PTCA DEB arm will receive lesion preparation according to the 3rd drug coated balloon (DCB) consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, intravascular lithotripsy, laser, rotational or orbital atherectomy, cutting or scoring balloon at the discretion of the operator as needed to reduce diameter stenosis to ≤ 30%). Subjects with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30%) will receive a DES instead of the SELUTION DEB but remain in the SELUTION DEB group (intention to treat analysis). The DEB should not be used after DES implant.
  • Control (DES): Subjects randomized to the DES arm will receive treatment using any FDA approved "limus-based" DES, as per standard institutional practice.

Angiographic Substudy:

The angiographic substudy is a parallel registry consisting of up to 30 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. These subjects will undergo angiography at 12 months post-procedure. Clinical follow-up will not extend beyond 12 months in this cohort.

Pharmacokinetic (pK) Substudy:

The pKsubstudy is a parallel registry consisting of up to 20 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. This study will be conducted under an approved substudy protocol and will include blood draws at regular intervals to characterize the pK plasma profile of sirolimus.

Primary Endpoint:

Target lesion failure (TLF), defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months. MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.

Being tested
PCI with SELUTION SLR DCB, PCI with FDA approved "-limus" DES
Keywords
CAD, DCB, DEB, NSTEMI, Stable Angina, Chronic Coronary Syndrome, CCS, Drug Coated Balloons, Drug Eluting Balloons, Small Vessels, SELUTIONSLR, Sirolimus
Medical subject headings
Coronary Artery Disease, Non-ST Elevated Myocardial Infarction, Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCI with SELUTION SLR DCBDevice

    After target lesion pre-dilatation and preparation , a SELUTION SLR 014 PTCA DEB study device should be selected with nominal diameter equal to the RVD of the target lesion (1:1 ratio) and length that allows approximately 2.00 mm longer than the proximal and distal edges of the target lesion (defined as the proximal and distal extent of predilation). If IVUS is performed to assess RVD, and DEB upsizing is deemed clinically necessary for optimal results, a maximum nominal DEB diameter of 3.0 mm is permitted. The SELUTION SLR 014 PTCA DEB should then be delivered, positioned in and deployed per instructions per use. The balloon should be inflated for 60 seconds provided that the patient can tolerate this duration. The minimum inflation time is 30 seconds.

  • PCI with FDA approved "-limus" DESDevice

    For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.

    The DES should be sized per IFU with respect to the vessel RVD. The use of IVUS or OCT is encouraged to guide optimal stent placement and assess final results. After DES deployment, additional balloon inflations should be performed as needed to obtain < 30% residual diameter stenosis and resolve proximal or distal edge dissections greater than or equal to NHLBI grade B.

Study groups in NCT05946629
Study groupRoleWhat they receive
SELUTION SLR 014 PTCA DEBExperimentalSELUTION Sustained Limus Release (SLR) 014 Percutaneous Transluminal Coronary Angioplasty (PTCA) Drug Eluting Balloon (DEB) The SELUTION SLR 014 PTCA DEB is a minimally invasive, single use and sterile Sirolimus coated PTCA balloon catheter. The SELUTION SLR 014 PTCA DEB is available with balloon diameters from 2.0 to 3.0 mm and lengths of 15 to 40 mm for the purpose of the De Novo IDE trial
Receives: Device: PCI with SELUTION SLR DCB
Control TreatmentActive comparatorany FDA approved "limus-based" Drug Eluting Stent, as per standard institutional practice
Receives: Device: PCI with FDA approved "-limus" DES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesion failure (TLF)

    Target lesion failure (TLF) is defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months.

    MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.

    Measured: 12 months

  2. PK Sub-study Primary Endpoint 1

    PK parameters of C(max)

    Measured: 6 months

  3. PK Sub-study Primary Endpoint 2

    PK parameters of T(max)

    Measured: 6 months

  4. PK Sub-study Primary Endpoint 3

    PK parameters of AUC(last)

    Measured: 6 months

  5. PK Sub-study Primary Endpoint 4

    PK parameters of MRT(last)

    Measured: 6 months

Secondary outcomes (17)

  1. Secondary Endpoint 1

    Composite of all-cause mortality, target vessel MI or clinically driven target lesion revascularization

    Measured: 12 months

  2. Secondary Endpoint 2

    Lesion success, defined as attainment of < 30% residual stenosis of target lesion using any percutaneous method

    Measured: Up to 7 days

  3. Secondary Endpoint 3

    Procedure success, defined as attainment of < 30% residual stenosis of the target lesion using the assigned study device only without the occurrence of in-hospital major adverse cardiac events (MACE), composite of all-cause death, MI or any clinically-driven TLR.

    Measured: Up to 7 days

  4. Secondary Endpoint 4

    Composite safety endpoint, defined as the patient-oriented composite of any death, any MI (spontaneous or peri-procedural), or any repeat revascularization.

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  5. Secondary Endpoint 5

    All-Cause Mortality

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  6. Secondary Endpoint 6

    Cardiovascular Mortality

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  7. Secondary Endpoint 7

    MI (spontaneous MI using the 4th UDMI, peri-procedural MI using SCAI and Academic Research Consortium [ARC]-2 definitions)

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  8. Secondary Endpoint 8

    Clinically-driven TLR

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  9. Secondary Endpoint 9

    all TLR

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  10. Secondary Endpoint 10

    Clinically-driven Target Vessel Revascularization (TVR)

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  11. Secondary Endpoint 11

    all TVR

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  12. Secondary Endpoint 12

    Non-target lesion revascularization

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  13. Secondary Endpoint 13

    TLF

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  14. Secondary Endpoint 14

    Target vessel failure (TVF), defined as a composite of: cardiac death, target vessel MI (spontaneous or peri-procedural) and any clinically-driven TVR

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  15. Secondary Endpoint 15

    Stent or target lesion segment thrombosis (definite or probable) according to the ARC criteria for acute, subacute, late, very late and cumulative stent thrombosis

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

  16. Secondary Endpoint 16

    Bleeding Academic Research Consortium (BARC) class 2-5

    Measured: 12 months

  17. Secondary Endpoint 17

    Net adverse clinical events, defined as death, MI (spontaneous or peri-procedural), TVR, stent/target lesion segment thrombosis or bleeding (BARC types 2-5, assessed to 12 months)

    Measured: Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start20 Oct 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2031 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Single-Blind Randomized Control Trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05946629
Sponsor's protocol ID
SEL-003-2021
Status last verified
Sep 2026
First submitted
30 Jun 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing PCI with SELUTION SLR DCB and PCI with FDA approved "-limus" DES in people with Coronary Artery Disease, run by M.A. Med Alliance S.A. at 70 sites in 3 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 21 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Germany, Belgium. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion failure (TLF) (time frame: 12 months). The study lists 5 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 NCT05946629.

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 24 Sep 2026.

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