Peripheral Arterial DiseasePhase 4VSTAR-PNCT07076082

Vascular Trial Associated Registry Pilot

A Phase 4 study testing Clopidogrel (Plavix) Pharmacogenetic Test Reagents in people with Peripheral Arterial Disease, run by Corewell Health West at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: Clopidogrel (Plavix) Pharmacogenetic Test Reagents
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 2 sitesUnited States
Study dates: 15 Oct 2025to 30 Oct 2028
Phase: Phase 4
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age greater than or equal to 45 at time of enrollment
Patient is scheduled for a PVI or has recently had a PVI in the last 30 days
Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry.
Atherosclerotic vascular disease

Who cannot join

Patients who cannot consent for themselves
Allergy to Clopidogrel
Patients unable to stop clopidogrel for other medical reasons
Patients on dual pathway inhibition (DPI) with low dose rivaroxaban (2.5mg twice a day) that are unable to stop these medications
Allergy to aspirin
Nonatherosclerotic vascular disease

Show all 14Show fewer

Patients undergoing open bypass at the same time as the peripheral transcutaneous angioplasty
Patients with high bleeding risk (HBR) defined as:
History of major bleeding, active bleeding disorder, severe renal impairment (CrCl <30), concurrent anticoagulation, platelet count <100,000
Recent stroke (within 6 months)
Current warfarin therapy or full dose therapeutic direct oral anticoagulants (DOAC).
Patients unwilling or unable to comply with standard of care follow-up visits
Pregnant women
Prisoners

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephen C Orey, MS contact

6163916660

Stephen.orey@corewellhealth.org

United States2 sites, 2 recruiting

Henry Ford Hospital
Detroit, Michigan, 48202-2608
Sarah Meehan, (313) 916-9387, smeehan1@hfhs.org
Loay Kabbani, MD
Recruiting
Corewell Health West
Grand Rapids, Michigan, 49503
Stephen C Orey, MS, 6163916660, Stephen.orey@corewellhealth.org
Recruiting

Other trials in United States

About this study

Official title: Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization

The purpose of this investigator-initiated, multicenter, open label, randomized trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization. We hypothesize that extending dual antiplatelet therapy (DAPT) to six months, compared to one month, will improve patency rates of target vessels following peripheral vascular intervention (PVI) without significantly increasing complications, particularly bleeding events.

Read the detailed description

The Main Objective of this study is to create an investigator-initiated, multicenter, open label, randomized trial to evaluate 1 month vs. 6 months of DAPT in patients undergoing lower extremity endovascular revascularization. The randomization will be 1:1 within one strata (diabetes yes/no), using blocks of varying sizes. All patients will be on DAPT for one month. At the time of the one-month visit, eligible patients who consent will be randomized to single antiplatelet therapy (SAPT) indefinitely (Arm 1) or to DAPT for 5 more months (followed by SAPT) (Arm 2). Follow-up will continue for 12-months post-procedure and will include assessment of MACE and MALE, as well as adverse bleeding events. Data for this trial will be collected via nested participation in the VQI Peripheral Vascular Intervention (PVI) registry's existing Procedural and Follow-up data collection modules.

Conditions: Peripheral Arterial Disease
Being tested: Clopidogrel (Plavix) Pharmacogenetic Test Reagents
Keywords: Peripheral Vascular Disease (PVD), Peripheral Vascular Intervention (PVI), Dual Antiplatelet therapy (DAPT), Peripheral Arterial Disease (PAD)
Medical subject headings: Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

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

Clopidogrel (Plavix) Pharmacogenetic Test ReagentsDrug
Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (clopidogrel) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).

Study groups in NCT07076082
Study group	Role	What they receive
Dual antiplatelet therapy 1-Month followed by single antiplatelet therapy indefinitely	Active comparator	Aspirin and Clopidogrel (Plavix) for 1-month post-procedure followed by Aspirin indefinitely. Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day). Receives: Drug: Clopidogrel (Plavix) Pharmacogenetic Test Reagents
Dual antiplatelet therapy 6-Month followed by single antiplatelet therapy indefinitely	Active comparator	Aspirin and Clopidogrel (Plavix) for 6-months post-procedure followed by Aspirin indefinitely. Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day). Receives: Drug: Clopidogrel (Plavix) Pharmacogenetic Test Reagents

What is being measured

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

The proportion of patients eligible who are offered study enrollment
Patients who undergo PVI that meet inclusion criteria and are offered enrollment.
Measured: 1 year
The proportion of eligible patients who consent to enrollment and randomization
Patients who meet inclusion criteria and agree to participate in trial vs those that do not agree to participate in trial
Measured: 1 year
The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
Measured: 6-months
The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
Measured: 1 year
The numbers and proportions of patients who have each type of major event
Of the enrolled patients that have a medical primary event how many individuals were in each category stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
Measured: 1 year
The proportions of patients who have major event status recorded at each observation time
Major event status at 1, 6-months post PVI and 12-month post PVI
Measured: 1 year

Timeline

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

15 Oct 202530 Oct 2028

First posted21 Jul 2025
Study start15 Oct 2025
Primary completion30 Oct 2027 (estimated)
Study completion30 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Peripheral Arterial DiseaseStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Investigator-initiated, multicenter, open label, randomized trial to evaluate 1 month vs. 6 months of DAPT in patients undergoing lower extremity endovascular revascularization. The randomization will be 1:1 within two strata (research site and diabetes yes/no), using blocks of varying sizes. All patients will be on DAPT for one month. At the time of the one-month visit, eligible patients who consent will be randomized to single antiplatelet therapy (SAPT) indefinitely (Arm 1) or to DAPT for 5 more months (followed by SAPT) (Arm 2). Follow-up will continue for 12-months post-procedure and will include assessment of MACE and MALE, as well as adverse bleeding events.
Masking: None (open label)
Enrolment: 350 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07076082
Sponsor's protocol ID: 2025-1010
Acronym: VSTAR-P
Status last verified: Jul 2026
First submitted: 17 Jul 2025
Last updated: 16 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Aday AW, Gutierrez JA. Antiplatelet Therapy Following Peripheral Arterial Interventions: The Choice Is Yours. Circ Cardiovasc Interv. 2020 Aug;13(8):e009727. doi: 10.1161/CIRCINTERVENTIONS.120.009727. Epub 2020 Aug 14. No abstract available.
PubMed 32791949
Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Fabry-Ribaudo L, Hu T, Topol EJ, Fox KA; CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007 May 15;49(19):1982-8. doi: 10.1016/j.jacc.2007.03.025. Epub 2007 Apr 11.
PubMed 17498584
Durand-Zaleski I, Bertrand M. The value of clopidogrel versus aspirin in reducing atherothrombotic events: the CAPRIE study. Pharmacoeconomics. 2004;22 Suppl 4:19-27. doi: 10.2165/00019053-200422004-00005.
PubMed 15876009
Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14.
PubMed 38743805
Writing Committee Members; Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024 Jun 18;83(24):2497-2604. doi: 10.1016/j.jacc.2024.02.013. Epub 2024 May 14.
PubMed 38752899
Tsai SY, Li YS, Lee CH, Cha SW, Wang YC, Su TW, Yu SY, Yeh CH. Mono or Dual Antiplatelet Therapy for Treating Patients with Peripheral Artery Disease after Lower Extremity Revascularization: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2022 May 12;15(5):596. doi: 10.3390/ph15050596.
PubMed 35631422
Nguyen T, Jokisch C, Dargan C, Janjua H, Brooks J, Moudgill N, Latz C, Shames M. The Effects of Clopidogrel Duration on Carotid Artery In-Stent Restenosis. Ann Vasc Surg. 2024 Jun;103:68-73. doi: 10.1016/j.avsg.2023.12.064. Epub 2024 Feb 11.
PubMed 38350539

Interested in taking part?

Stephen C Orey, MS

6163916660

Stephen.orey@corewellhealth.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization
ClinicalTrials.gov ID: NCT07076082
Acronym / sponsor ID: VSTAR-P / 2025-1010
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Vascular Disease (PVD), Peripheral Vascular Intervention (PVI), Dual Antiplatelet therapy (DAPT), Peripheral Arterial Disease (PAD)
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 350 participants (estimated)
Lead sponsor: Corewell Health WestUniversity, hospital or other
Collaborators: Henry Ford Hospital
Study start: 15 Oct 2025 (actual)
Primary completion: 30 Oct 2027 (estimated)
Study completion: 30 Oct 2028 (estimated)
First posted: 21 Jul 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Investigator-initiated, multicenter, open label, randomized trial to evaluate 1 month vs. 6 months of DAPT in patients undergoing lower extremity endovascular revascularization. The randomization will be 1:1 within two strata (research site and diabetes yes/no), using blocks of varying sizes. All patients will be on DAPT for one month. At the time of the one-month visit, eligible patients who consent will be randomized to single antiplatelet therapy (SAPT) indefinitely (Arm 1) or to DAPT for 5 more months (followed by SAPT) (Arm 2). Follow-up will continue for 12-months post-procedure and will include assessment of MACE and MALE, as well as adverse bleeding events.

Arm	Type	Receives
Dual antiplatelet therapy 1-Month followed by single antiplatelet therapy indefinitely	Active comparator	Drug: Clopidogrel (Plavix) Pharmacogenetic Test ReagentsAspirin and Clopidogrel (Plavix) for 1-month post-procedure followed by Aspirin indefinitely. Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).
Dual antiplatelet therapy 6-Month followed by single antiplatelet therapy indefinitely	Active comparator	Drug: Clopidogrel (Plavix) Pharmacogenetic Test ReagentsAspirin and Clopidogrel (Plavix) for 6-months post-procedure followed by Aspirin indefinitely. Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age greater than or equal to 45 at time of enrollment
Patient is scheduled for a PVI or has recently had a PVI in the last 30 days
Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry.
Atherosclerotic vascular disease

Key exclusion criteria (14 listed)

Patients who cannot consent for themselves
Allergy to Clopidogrel
Patients unable to stop clopidogrel for other medical reasons
Patients on dual pathway inhibition (DPI) with low dose rivaroxaban (2.5mg twice a day) that are unable to stop these medications
Allergy to aspirin

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
Clopidogrel (Plavix) Pharmacogenetic Test ReagentsDual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (clopidogrel) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).	Drug	Dual antiplatelet therapy 1-Month followed by single antiplatelet therapy indefinitely, Dual antiplatelet therapy 6-Month followed by single antiplatelet therapy indefinitely

Primary outcome

The proportion of patients eligible who are offered study enrollment
Time frame: 1 year
Patients who undergo PVI that meet inclusion criteria and are offered enrollment.
The proportion of eligible patients who consent to enrollment and randomization
Time frame: 1 year
Patients who meet inclusion criteria and agree to participate in trial vs those that do not agree to participate in trial
The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months
Time frame: 6-months
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months
Time frame: 1 year
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
The numbers and proportions of patients who have each type of major event
Time frame: 1 year
Of the enrolled patients that have a medical primary event how many individuals were in each category stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
The proportions of patients who have major event status recorded at each observation time
Time frame: 1 year
Major event status at 1, 6-months post PVI and 12-month post PVI

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 Jul 2026.
Background: PubMed 32791949Aday AW, Gutierrez JA. Antiplatelet Therapy Following Peripheral Arterial Interventions: The Choice Is Yours. Circ Cardiovasc Interv. 2020 Aug;13(8):e009727. doi: 10.1161/CIRCINTERVENTIONS.120.009727. Epub 2020 Aug 14. No abstract available.
Background: PubMed 17498584Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Fabry-Ribaudo L, Hu T, Topol EJ, Fox KA; CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007 May 15;49(19):1982-8. doi: 10.1016/j.jacc.2007.03.025. Epub 2007 Apr 11.
Background: PubMed 15876009Durand-Zaleski I, Bertrand M. The value of clopidogrel versus aspirin in reducing atherothrombotic events: the CAPRIE study. Pharmacoeconomics. 2004;22 Suppl 4:19-27. doi: 10.2165/00019053-200422004-00005.
Background: PubMed 38743805Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14.
Background: PubMed 38752899Writing Committee Members; Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024 Jun 18;83(24):2497-2604. doi: 10.1016/j.jacc.2024.02.013. Epub 2024 May 14.
Background: PubMed 35631422Tsai SY, Li YS, Lee CH, Cha SW, Wang YC, Su TW, Yu SY, Yeh CH. Mono or Dual Antiplatelet Therapy for Treating Patients with Peripheral Artery Disease after Lower Extremity Revascularization: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2022 May 12;15(5):596. doi: 10.3390/ph15050596.
Background: PubMed 38350539Nguyen T, Jokisch C, Dargan C, Janjua H, Brooks J, Moudgill N, Latz C, Shames M. The Effects of Clopidogrel Duration on Carotid Artery In-Stent Restenosis. Ann Vasc Surg. 2024 Jun;103:68-73. doi: 10.1016/j.avsg.2023.12.064. Epub 2024 Feb 11.
Individual participant dataSharing planned: No

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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.

Stephen C Orey, MS contact

6163916660

Stephen.orey@corewellhealth.org

Vikram C Kashyap, MD principal investigator

Corewell Health West

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel (Plavix) Pharmacogenetic Test Reagents in people with Peripheral Arterial Disease, run by Corewell Health West at 2 sites in United States.

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 4 inclusion and 14 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Stephen C Orey, MS (6163916660, Stephen.orey@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients eligible who are offered study enrollment (time frame: 1 year). The study lists 6 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 NCT07076082, which also lists 7 linked publications.

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 Jul 2026.