Peripheral Vascular DiseasesNCT06782100
MRI Guided Management of Occlusive Peripheral Arterial Disease
An observational study of Peripheral Vascular Diseases, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Jun 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: For Revascularization Arm: Patients will be enrolled from Vascular surgical Care at Houston Methodist Hospital and undergoing lower limb PVI. For Amputation Arm: Patients undergoing Major lower limb amputation at Houston Methodist Hospital with PAD.
Who may be able to join
- General Inclusion Criteria:
- All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6)
- Anatomic inclusion criteria:
- At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with > 50% stenosis by investigator visual estimate
Who cannot join
- General Exclusion Criteria:
- Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications
- Anatomic Exclusion Criteria:
- Aim 2 only - Chronic total occlusions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Trisha Roy, MD, PhD, 713-441-5200, troy@houstonmethodist.org
Janak Lamichhane, MBBS, MBA, 346- 238-2291, jlamichhane@houstonmethodist.org
About this study
The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury.
Patients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty.
Patients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.
Read the detailed description
Please see attached study protocol.
- Conditions
- Peripheral Vascular Diseases
- Keywords
- MRI Guided Management of Occlusive Peripheral Arterial Disease, PAD, Peripheral Vascular Disease, PVI, MRI, MRA
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amputation Arm | In an ex vivo human cadaveric model, post-PVI histopathologic analysis will be used to uncover the impact of plaque type on device safety (POBA versus atherectomy) and performance, facilitating evidence-based device selection to mitigate complications. Using a randomized approach, the investigator will compare plain balloon angioplasty to orbital atherectomy prior to angioplasty in amputated legs from PAD patients with plaques characterized into 4 categories based their MRI-histology: concentric calcium, eccentric calcium, fibrous plaque, and soft plaques (smooth muscle and thrombus). | |
| Revascularization Arm | Patient Imaging Protocol: Scans will be performed on 100 patients enrolled into the study population using a 3T MAGNETOM scanner (Siemens) at the Houston Methodist Research Institute Translational Imaging Center. The investigator will use pre-operative images captured using the optimized MRI-histology sequences to score lesions. Physicians performing PVI will be blinded to the pre-operative MRI-histology images and anatomic scores and will make treatment decisions based on their standard of care. The investigator expect MRI-histology plaque scores predict which patients will have PVI failures due to untraversable plaque, and it may also foresee the potential need of adjunctive devices or alternative approaches for successful PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient primary Outcome
PVI failure due to inability to cross the target plaque with a guidewire.
Measured: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.
Amputation Arm Outcome
Presence of dissections on histology (number of dissections i.e. count, idissection score)
Measured: From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis)
Secondary outcomes (3)
Patient outcome measures
- Plaque-crossing time (seconds),
- successful target lesion revascularization (yes or no)
- use of adjunct devices beyond plain balloon angioplasty (record name of device[s])
- injury/dissection of vessel requiring stent (record event title e.g. dissection)
- plaque embolization (yes/no)
- number and stiffness of wires and catheters used (record device names)
- subintimal crossing (yes/no)
- outcomes after antegrade/retrograde access (successful/unsuccessful)
Measured: Intraprocedural
Amputation Arm Outcomes
- Minimal inflation pressure
- mean luminal gain percentage based on IVUS
- severity of dissections using iDissection classification and
- endothelial injury
Measured: From Experiment and Histologicla Examination
Patient Outcome Measure
Hypothesis: Women will have less MRI-defined hard lesions and plaques that are easier to cross Comparison Groups: Women vs. Men Primary Outcome: PVI failure due to inability to cross the target plaque with a guidewire (record number of hard lesions i.e. count, comparing men and women)
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Jul 2024
- Primary completion1 Jul 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Triisha Roy, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782100
- Sponsor's protocol ID
- PRO00027258
- Other IDs
- R01HL174587
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Based on ethical and legal considerations, only the following data produced in the course of the project will be preserved and shared on a data repository platform: MRI, angiography, Cone Beam CT, and histology data.The final dataset will include self-reported demographic data. We will share de-identified individualparticipant level (IPD) data. Appropriate measures such as assigning a random code to each participant will be used for data de-identification and sharing, and informed consent forms will reflect those plans.
Publications
Csore J, Karmonik C, Wilhoit K, Buckner L, Roy TL. Automatic Classification of Magnetic Resonance Histology of Peripheral Arterial Chronic Total Occlusions Using a Variational Autoencoder: A Feasibility Study. Diagnostics (Basel). 2023 May 31;13(11):1925. doi: 10.3390/diagnostics13111925.
PubMed 37296778Barisano G, Sepehrband F, Ma S, Jann K, Cabeen R, Wang DJ, Toga AW, Law M. Clinical 7 T MRI: Are we there yet? A review about magnetic resonance imaging at ultra-high field. Br J Radiol. 2019 Feb;92(1094):20180492. doi: 10.1259/bjr.20180492. Epub 2018 Nov 1.
PubMed 30359093Shammas NW, Shammas WJ, Jones-Miller S, Torey JT, Armstrong EJ, Radaideh Q, Shammas GA. Optimal Vessel Sizing and Understanding Dissections in Infrapopliteal Interventions: Data From the iDissection Below the Knee Study. J Endovasc Ther. 2020 Aug;27(4):575-580. doi: 10.1177/1526602820924815. Epub 2020 May 18.
PubMed 32419593Horie K, Tanaka A, Taguri M, Kato S, Inoue N. Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions. J Endovasc Ther. 2018 Dec;25(6):683-691. doi: 10.1177/1526602818799733. Epub 2018 Sep 11.
PubMed 30203701Ebisawa S, Kohsaka S, Muramatsu T, Kashima Y, Okamura A, Yamane M, Sakurada M, Matsuno S, Kijima M, Habara M. Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions. PLoS One. 2020 Sep 11;15(9):e0238640. doi: 10.1371/journal.pone.0238640. eCollection 2020.
PubMed 32915843Werncke T, Ringe KI, von Falck C, Kruschewski M, Wacker F, Meyer BC. Diagnostic confidence of run-off CT-angiography as the primary diagnostic imaging modality in patients presenting with acute or chronic peripheral arterial disease. PLoS One. 2015 Apr 2;10(3):e0119900. doi: 10.1371/journal.pone.0119900. eCollection 2015.
PubMed 25835948Mohebali J, Patel VI, Romero JM, Hannon KM, Jaff MR, Cambria RP, LaMuraglia GM. Acoustic shadowing impairs accurate characterization of stenosis in carotid ultrasound examinations. J Vasc Surg. 2015 Nov;62(5):1236-44. doi: 10.1016/j.jvs.2015.06.137.
PubMed 26506272Roy T, Liu G, Shaikh N, Dueck AD, Wright GA. Puncturing Plaques. J Endovasc Ther. 2017 Feb;24(1):35-46. doi: 10.1177/1526602816671135. Epub 2016 Sep 25.
PubMed 27659155Ebert MLA, Schmidt VF, Pfaff L, von Thaden A, Kimm MA, Wildgruber M. Animal Models of Neointimal Hyperplasia and Restenosis: Species-Specific Differences and Implications for Translational Research. JACC Basic Transl Sci. 2021 Aug 11;6(11):900-917. doi: 10.1016/j.jacbts.2021.06.006. eCollection 2021 Nov.
PubMed 34869956Hsu CC, Kwan GN, Singh D, Rophael JA, Anthony C, van Driel ML. Angioplasty versus stenting for infrapopliteal arterial lesions in chronic limb-threatening ischaemia. Cochrane Database Syst Rev. 2018 Dec 8;12(12):CD009195. doi: 10.1002/14651858.CD009195.pub2.
PubMed 30536919Jones DW, Schanzer A, Zhao Y, MacKenzie TA, Nolan BW, Conte MS, Goodney PP; Vascular Study Group of New England. Growing impact of restenosis on the surgical treatment of peripheral arterial disease. J Am Heart Assoc. 2013 Nov 25;2(6):e000345. doi: 10.1161/JAHA.113.000345.
PubMed 24275626Nolan BW, De Martino RR, Stone DH, Schanzer A, Goodney PP, Walsh DW, Cronenwett JL; Vascular Study Group of New England. Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor outcome after lower extremity bypass. J Vasc Surg. 2011 Sep;54(3):730-5; discussion 735-6. doi: 10.1016/j.jvs.2011.03.236. Epub 2011 Jul 29.
PubMed 21802888Roy TL, Chen HJ, Dueck AD, Wright GA. Magnetic resonance imaging characteristics of lesions relate to the difficulty of peripheral arterial endovascular procedures. J Vasc Surg. 2018 Jun;67(6):1844-1854.e2. doi: 10.1016/j.jvs.2017.09.034. Epub 2017 Dec 13.
PubMed 29248239Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L, Chetter I, Diamantopoulos A, Ganeshan A, Hall J, Hobbs S, Houlind K, Jarrett H, Lockyer S, Malmstedt J, Patel JV, Patel S, Rashid ST, Saratzis A, Slinn G, Scott DJA, Zayed H, Deeks JJ; BASIL-2 Investigators. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet. 2023 May 27;401(10390):1798-1809. doi: 10.1016/S0140-6736(23)00462-2. Epub 2023 Apr 25.
PubMed 37116524Kristensen MT, Holm G, Kirketerp-Moller K, Krasheninnikoff M, Gebuhr P. Very low survival rates after non-traumatic lower limb amputation in a consecutive series: what to do? Interact Cardiovasc Thorac Surg. 2012 May;14(5):543-7. doi: 10.1093/icvts/ivr075. Epub 2012 Jan 31.
PubMed 22298857
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Guided Management of Occlusive Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT06782100
- Acronym / sponsor ID
- PRO00027258
- Conditions
- Peripheral Vascular Diseases
- Keywords
- MRI Guided Management of Occlusive Peripheral Arterial Disease, PAD, Peripheral Vascular Disease, PVI, MRI, MRA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 Jan 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.
The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury.
Patients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty.
Patients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.
Detailed description
Please see attached study protocol.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amputation Arm | – | –In an ex vivo human cadaveric model, post-PVI histopathologic analysis will be used to uncover the impact of plaque type on device safety (POBA versus atherectomy) and performance, facilitating evidence-based device selection to mitigate complications. Using a randomized approach, the investigator will compare plain balloon angioplasty to orbital atherectomy prior to angioplasty in amputated legs from PAD patients with plaques characterized into 4 categories based their MRI-histology: concentric calcium, eccentric calcium, fibrous plaque, and soft plaques (smooth muscle and thrombus). |
| Revascularization Arm | – | –Patient Imaging Protocol: Scans will be performed on 100 patients enrolled into the study population using a 3T MAGNETOM scanner (Siemens) at the Houston Methodist Research Institute Translational Imaging Center. The investigator will use pre-operative images captured using the optimized MRI-histology sequences to score lesions. Physicians performing PVI will be blinded to the pre-operative MRI-histology images and anatomic scores and will make treatment decisions based on their standard of care. The investigator expect MRI-histology plaque scores predict which patients will have PVI failures due to untraversable plaque, and it may also foresee the potential need of adjunctive devices or alternative approaches for successful PVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For Revascularization Arm: Patients will be enrolled from Vascular surgical Care at Houston Methodist Hospital and undergoing lower limb PVI. For Amputation Arm: Patients undergoing Major lower limb amputation at Houston Methodist Hospital with PAD.
Key inclusion criteria (4 listed)
- General Inclusion Criteria:
- All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6)
- Anatomic inclusion criteria:
- At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with > 50% stenosis by investigator visual estimate
Key exclusion criteria (4 listed)
- General Exclusion Criteria:
- Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications
- Anatomic Exclusion Criteria:
- Aim 2 only - Chronic total occlusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient primary Outcome
Time frame: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.
PVI failure due to inability to cross the target plaque with a guidewire.
Amputation Arm Outcome
Time frame: From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis)
Presence of dissections on histology (number of dissections i.e. count, idissection score)
3 secondary outcomes
Patient outcome measures
Time frame: Intraprocedural
Amputation Arm Outcomes
Time frame: From Experiment and Histologicla Examination
Patient Outcome Measure
Time frame: Intraprocedural
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 19 Mar 2026.
- Background: PubMed 37296778Csore J, Karmonik C, Wilhoit K, Buckner L, Roy TL. Automatic Classification of Magnetic Resonance Histology of Peripheral Arterial Chronic Total Occlusions Using a Variational Autoencoder: A Feasibility Study. Diagnostics (Basel). 2023 May 31;13(11):1925. doi: 10.3390/diagnostics13111925.
- Background: PubMed 30359093Barisano G, Sepehrband F, Ma S, Jann K, Cabeen R, Wang DJ, Toga AW, Law M. Clinical 7 T MRI: Are we there yet? A review about magnetic resonance imaging at ultra-high field. Br J Radiol. 2019 Feb;92(1094):20180492. doi: 10.1259/bjr.20180492. Epub 2018 Nov 1.
- Background: PubMed 32419593Shammas NW, Shammas WJ, Jones-Miller S, Torey JT, Armstrong EJ, Radaideh Q, Shammas GA. Optimal Vessel Sizing and Understanding Dissections in Infrapopliteal Interventions: Data From the iDissection Below the Knee Study. J Endovasc Ther. 2020 Aug;27(4):575-580. doi: 10.1177/1526602820924815. Epub 2020 May 18.
- Background: PubMed 30203701Horie K, Tanaka A, Taguri M, Kato S, Inoue N. Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions. J Endovasc Ther. 2018 Dec;25(6):683-691. doi: 10.1177/1526602818799733. Epub 2018 Sep 11.
- Background: PubMed 32915843Ebisawa S, Kohsaka S, Muramatsu T, Kashima Y, Okamura A, Yamane M, Sakurada M, Matsuno S, Kijima M, Habara M. Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions. PLoS One. 2020 Sep 11;15(9):e0238640. doi: 10.1371/journal.pone.0238640. eCollection 2020.
- Background: PubMed 25835948Werncke T, Ringe KI, von Falck C, Kruschewski M, Wacker F, Meyer BC. Diagnostic confidence of run-off CT-angiography as the primary diagnostic imaging modality in patients presenting with acute or chronic peripheral arterial disease. PLoS One. 2015 Apr 2;10(3):e0119900. doi: 10.1371/journal.pone.0119900. eCollection 2015.
- Background: PubMed 26506272Mohebali J, Patel VI, Romero JM, Hannon KM, Jaff MR, Cambria RP, LaMuraglia GM. Acoustic shadowing impairs accurate characterization of stenosis in carotid ultrasound examinations. J Vasc Surg. 2015 Nov;62(5):1236-44. doi: 10.1016/j.jvs.2015.06.137.
- Background: PubMed 27659155Roy T, Liu G, Shaikh N, Dueck AD, Wright GA. Puncturing Plaques. J Endovasc Ther. 2017 Feb;24(1):35-46. doi: 10.1177/1526602816671135. Epub 2016 Sep 25.
- Background: PubMed 34869956Ebert MLA, Schmidt VF, Pfaff L, von Thaden A, Kimm MA, Wildgruber M. Animal Models of Neointimal Hyperplasia and Restenosis: Species-Specific Differences and Implications for Translational Research. JACC Basic Transl Sci. 2021 Aug 11;6(11):900-917. doi: 10.1016/j.jacbts.2021.06.006. eCollection 2021 Nov.
- Background: PubMed 30536919Hsu CC, Kwan GN, Singh D, Rophael JA, Anthony C, van Driel ML. Angioplasty versus stenting for infrapopliteal arterial lesions in chronic limb-threatening ischaemia. Cochrane Database Syst Rev. 2018 Dec 8;12(12):CD009195. doi: 10.1002/14651858.CD009195.pub2.
- Background: PubMed 24275626Jones DW, Schanzer A, Zhao Y, MacKenzie TA, Nolan BW, Conte MS, Goodney PP; Vascular Study Group of New England. Growing impact of restenosis on the surgical treatment of peripheral arterial disease. J Am Heart Assoc. 2013 Nov 25;2(6):e000345. doi: 10.1161/JAHA.113.000345.
- Background: PubMed 21802888Nolan BW, De Martino RR, Stone DH, Schanzer A, Goodney PP, Walsh DW, Cronenwett JL; Vascular Study Group of New England. Prior failed ipsilateral percutaneous endovascular intervention in patients with critical limb ischemia predicts poor outcome after lower extremity bypass. J Vasc Surg. 2011 Sep;54(3):730-5; discussion 735-6. doi: 10.1016/j.jvs.2011.03.236. Epub 2011 Jul 29.
- Individual participant dataSharing planned: Yes. Based on ethical and legal considerations, only the following data produced in the course of the project will be preserved and shared on a data repository platform: MRI, angiography, Cone Beam CT, and histology data.The final dataset will include self-reported demographic data. We will share de-identified individualparticipant level (IPD) data. Appropriate measures such as assigning a random code to each participant will be used for data de-identification and sharing, and informed consent forms will reflect those plans.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases, run by The Methodist Hospital Research Institute at 1 site 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 4 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Trisha Roy, MD, PhD (713-441-5200, troy@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient primary Outcome (time frame: Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.). The study lists 2 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 NCT06782100, which also lists 21 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 19 Mar 2026.