Peripheral Arterial DiseaseTORUS2NCT04130737
The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study
A study testing TORUS Stent Graft System in people with Peripheral Arterial Disease, run by Endologix at 32 sites in United States.
Trial summary
The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- TORUS Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 32 sitesUnited States
- Study dates
- 13 Aug 2018to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment.
- Patient provides written informed consent before any study-specific investigations or procedures.
- Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
- Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
- Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery.
- Patient has PAD classified as Rutherford classification 2, 3 or 4.
Show all 14Show fewer
- Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be <0.70; or (ii) Normal ABI with angiographic, ultrasound, MRA, or CT evidence of ≥ 60% diameter stenosis.
- Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
- Single target lesion must be covered by a single stent. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and > 30% diameter stenosis between the lesion(s).
- Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
- Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
- Target lesion measures ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and > 30% diameter stenosis between the lesion(s).
- Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
- Patient has at least one patent infrapopliteal vessel (< 50% stenosis) with run-off to the ankle.
Who cannot join
- Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits.
- Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
- Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
- Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
- Patient has a target vessel that has been treated with bypass surgery.
- Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
Show all 23Show fewer
- Patient has known or suspected active systemic infection at the time of enrollment.
- Patient has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR (international normalized ratio) >1.8.
- Patient has a stroke diagnosis within three months prior to enrollment.
- Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
- Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
- Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
- Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
- Patient has received thrombolysis within 72 hours prior to the index procedure.
- Patient has acute or chronic renal disease (e.g., as measured by a serum creatinine of > 2.5 mg/dL or > 220 μmol/L or GFR < 30 ml/min), or on peritoneal or hemodialysis.
- Patient requiring coronary intervention within seven days prior to enrollment.
- Patient is pregnant or breast-feeding.
- Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).
- Patient has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
- Patient has significant disease or obstruction (≥ 50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤ 30% residual stenosis, without complication).
- Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle.
- There is a lack of full expansion in the predilatation balloon.
- Evidence of aneurysm or acute thrombus in target vessel.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Rocky Mountain Regional VAMC
Aurora, Colorado, 80045
McLaren Bay Region
Bay City, Michigan, 48708
Bay Area Vein & Vascular Institute
Burlingame, California, 94010
Novant Health
Charlotte, North Carolina, 28204
The Lindner Center for Research & Education
Cincinnati, Ohio, 45219
The Vascular Experts
Darien, Connecticut, 06820
AMITA Health
Elk Grove, Illinois, 60007
Michigan Vascular Center
Flint, Michigan, 48507
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Bellin Hospital
Green Bay, Wisconsin, 54301
Prisma Health
Greenville, South Carolina, 29615
MedStar Health Research Insitute
Hyattsville, Maryland, 20782
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Arkansas Heart
Little Rock, Arkansas, 72211
Texas Tech
Lubbock, Texas, 79430
North Dallas Research Associates
McKinney, Texas, 75069
Southwest CVA
Mesa, Arizona, 85206
Vascular Heart & Lung Associates
Mesa, Arizona, 85206
Palm Vascular Centers
Miami Beach, Florida, 33140
Columbia University Medical Center
New York, New York, 10032
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Naadi
Oklahoma City, Oklahoma, 73116
Coastal Vascular & Interventional
Pensacola, Florida, 32504
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
The Miriam Hospital
Providence, Rhode Island, 02906
NC Heart & Vascular Research
Raleigh, North Carolina, 27607
Eastlake Cardiovascular
Roseville, Michigan, 48066
UCSF
San Francisco, California, 94143
North Central Heart
Sioux Falls, South Dakota, 57108
Northern Mississippi Medical Center
Tupelo, Mississippi, 38801
Florida Cardiology
Winter Park, Florida, 32792
Yuma Cardiology Associates
Yuma, Arizona, 85349
About this study
Official title: The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2
The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.
Read the detailed description
Peripheral Arterial Disease, specifically in the superficial femoral arteries (SFA) and proximal popliteal arteries, are treated by a range of alternative practices and procedures for the patient population identified in the indications for use statement. Non-invasive approaches include exercise and drug therapy.
Minimally-invasive approaches include endovascular intervention using percutaneous transluminal angioplasty using a plain or drug-coated balloon, stents (bare metal, drug-eluting and covered) and various modalities of atherectomy.
SFA Stent Graft Systems have a clinical history that demonstrates that this device type is well understood, and the benefits and risks are well-characterized, i.e. mature technology.
Endologix believes that the clinical performance of the TORUS stent would be comparable to marketed SFA Stent Graft System. The TORUS 2 IDE Clinical Study will confirm this and is designed to demonstrate the safety and effectiveness of the TORUS Stent Graft System in patients with SFA and/or proximal popliteal artery disease
- Conditions
- Peripheral Arterial Disease
- Being tested
- TORUS Stent Graft System
- Keywords
- Peripheral Artery Disease, Superficial Femoral Artery, Popliteal Artery, Stent Graft
- 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.
TORUS Stent Graft SystemDevice
Also called TORUS Stent Graft, PQ Bypass™ Stent Graft System
The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.
| Study group | Role | What they receive |
|---|---|---|
| TORUS Stent Graft System | Experimental | The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS). Receives: Device: TORUS Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From a Major Adverse Event (MAE)
An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)
Measured: 30 days
Primary Patency
Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5.
Measured: 12 months
Secondary outcomes (12)
Technical Success
Technical success is defined as the ability to cross and dilate the lesion to achieve residual stenosis of ≤30%
Measured: At the time of the index procedure
Procedural Success
Procedural Success is defined as technical success with out any MAEs.
Measured: Within 24 hours of the procedure
Major Adverse Event (MAE) Rate
Composite rate of all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR).
Measured: 12 months
Major Amputation on Target Limb
Major Amputation on Target Limb were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months
Measured: Through 36 months
Patency Rate
Absence of CD-TLR and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5.
Measured: Through 12 months
Clinically Driven Target Lesion Revascularization
Clinically Driven Target Lesion Revascularization were adjudicated by the Clinical Event Committee (CEC), and rates were tabulated through 30 days, 6 months, 12 months, 24 months, and 36 months
Measured: Through 36 months
Walking Improvement Questionnaire (WIQ) Assessment
Walking Impairment Questionnaire (WIQ) - The WIQ is a patient-reported outcome measure that assesses self-reported walking ability in individuals with peripheral arterial disease (PAD). It evaluates perceived difficulty performing walking tasks related to walking distance, walking speed, and stair climbing, which reflect functional limitations caused by PAD.
Scale Structure and Scoring:
The WIQ consists of three subscales:
Walking Distance Walking Speed Stair Climbing
Each subscale is scored from 0 to 100, where higher scores indicate better walking function.
The Composite PAD Score (PADSCORE) is calculated by averaging the three subscale scores, resulting in a total composite score ranging from 0 to 100.
Scale Ranges and Interpretation:
WIQ Subscale Scores: 0 (worst function) to 100 (best function) WIQ Composite PAD Score: 0 (worst walking impairment) to 100 (no walking impairment)
Direction of Outcome:
For all WIQ scores, higher values represent a better outcome
Measured: Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M)
Quality of Life Assessment by the EQ5D VAS
EuroQol Visual Analog Scale (EQ-5D-VAS) - The EQ-5D-VAS is a patient-reported outcome measure that assesses overall self-rated health-related quality of life. Participants rate their current health status using a visual analog scale anchored by the best and worst imaginable health states.
Scale Structure and Scoring:
Participants mark their perceived health status on a vertical visual analog scale.
Scale Range and Interpretation:
EQ-5D-VAS Score Range: 0 to 100
0: Worst imaginable health state (minimum) 100: Best imaginable health state (maximum)
Direction of Outcome:
Higher EQ-5D-VAS scores represent a better outcome, reflecting better perceived health-related quality of life. Lower scores indicate worse perceived health status.
Unit of Measure:
EQ-5D-VAS (scores on a scale)
Measured: Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M)
Stent Fracture Rate
Stent fracture rate using VIVA definitions
Measured: 12 months
Change in Ankle-Brachial Index
Change in Ankle-Brachial Index (ABI) in study subjects from baseline to each study interval through follow-up.
Scale Structure and Scoring:
Change in ABI was calculated as the difference between post-baseline ABI and baseline ABI for each participant for the target limb.
ABI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Therefore, interpretation is based on clinically established thresholds rather than absolute scale limits:
ABI ≤ 0.90: Consistent with peripheral arterial disease ABI 0.91-1.29: Generally considered normal arterial perfusion ABI ≥ 1.30: Suggestive of non-compressible arteries (e.g., arterial calcification)
Change in ABI:
Positive change (increase): Improvement in lower-extremity perfusion Negative change (decrease): Worsening arterial perfusion
Direction of Outcome:
For Change in ABI, higher (more positive) values represent a better outcome
Measured: Change from Baseline through 36 months
Change in Toe Pressures
Change in Toe-Brachial Index (TBI) in study subjects from baseline to each study interval through follow-up for the target limb. If ABI could not be assessed the TBI was assessed.
Scale Structure and Scoring:
TBI is calculated as:
TBI = Toe systolic blood pressure ÷ Brachial systolic blood pressure
Change in TBI was calculated as the difference between post-baseline TBI and baseline TBI for each participant.
Scale Range and Clinical Interpretation:
TBI is a unitless ratio and does not have a fixed theoretical minimum or maximum value. Interpretation is therefore based on clinically established thresholds rather than absolute scale limits:
TBI < 0.70: Consistent with peripheral arterial disease TBI ≥ 0.70: Generally considered normal digital perfusion
For Change in TBI:
A positive change (increase) indicates improvement in distal (digital) perfusion A negative change (decrease) indicates worsening arterial perfusion
Measured: Change from Baseline through 36 months
Change in Rutherford Clinical Classification
Clinical success: improvement in ≥ 1 Rutherford class
Measured: From procedure through 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start13 Aug 2018
- Primary completion6 Jan 2023
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx, PQ Bypass, Inc.
- Responsible party
- Sponsor
- Investigators
- Ehrin Armstrong,, MD, Principal investigator, Denver Veteran's Administration HospitalPeter Schneider,, MD, Principal investigator, University of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130737
- Sponsor's protocol ID
- CLN 227
- Acronym
- TORUS2
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2019
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2
- ClinicalTrials.gov ID
- NCT04130737
- Acronym / sponsor ID
- TORUS2 / CLN 227
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Artery Disease, Superficial Femoral Artery, Popliteal Artery, Stent Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx, PQ Bypass, Inc.
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Posted 10 Jul 2026
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 TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.
Detailed description
Peripheral Arterial Disease, specifically in the superficial femoral arteries (SFA) and proximal popliteal arteries, are treated by a range of alternative practices and procedures for the patient population identified in the indications for use statement. Non-invasive approaches include exercise and drug therapy.
Minimally-invasive approaches include endovascular intervention using percutaneous transluminal angioplasty using a plain or drug-coated balloon, stents (bare metal, drug-eluting and covered) and various modalities of atherectomy.
SFA Stent Graft Systems have a clinical history that demonstrates that this device type is well understood, and the benefits and risks are well-characterized, i.e. mature technology.
Endologix believes that the clinical performance of the TORUS stent would be comparable to marketed SFA Stent Graft System. The TORUS 2 IDE Clinical Study will confirm this and is designed to demonstrate the safety and effectiveness of the TORUS Stent Graft System in patients with SFA and/or proximal popliteal artery disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TORUS Stent Graft System | Experimental | Device: TORUS Stent Graft SystemThe TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment.
- Patient provides written informed consent before any study-specific investigations or procedures.
- Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
- Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
- Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery.
Key exclusion criteria (23 listed)
- Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits.
- Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
- Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
- Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
- Patient has a target vessel that has been treated with bypass surgery.
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 |
|---|---|---|
| TORUS Stent Graft SystemAlso: TORUS Stent Graft, PQ Bypass™ Stent Graft SystemThe TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature. | Device | TORUS Stent Graft System |
Primary outcome
Freedom From a Major Adverse Event (MAE)
Time frame: 30 days
An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)
Primary Patency
Time frame: 12 months
Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis >50% by duplex ultrasound with a peak systolic velocity ratio of >2.5.
12 secondary outcomes
Technical Success
Time frame: At the time of the index procedure
Procedural Success
Time frame: Within 24 hours of the procedure
Major Adverse Event (MAE) Rate
Time frame: 12 months
Major Amputation on Target Limb
Time frame: Through 36 months
Patency Rate
Time frame: Through 12 months
Clinically Driven Target Lesion Revascularization
Time frame: Through 36 months
Walking Improvement Questionnaire (WIQ) Assessment
Time frame: Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M)
Quality of Life Assessment by the EQ5D VAS
Time frame: Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M)
Stent Fracture Rate
Time frame: 12 months
Change in Ankle-Brachial Index
Time frame: Change from Baseline through 36 months
Change in Toe Pressures
Time frame: Change from Baseline through 36 months
Change in Rutherford Clinical Classification
Time frame: From procedure through 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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. This study is not recruiting at the moment.
Ehrin Armstrong,, MD principal investigator
Denver Veteran's Administration Hospital
Peter Schneider,, MD principal investigator
University of California
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TORUS Stent Graft System in people with Peripheral Arterial Disease, run by Endologix at 32 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 14 inclusion and 23 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: finished, as of the sponsor's last update on 10 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 32 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Freedom From a Major Adverse Event (MAE) (time frame: 30 days). 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?
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 10 Jul 2026.