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Peripheral Artery DiseaseiVESTNCT04748965

Imaging-Guided Vessel Sizing in the Tibial Arteries

An observational study of Peripheral Artery Disease and Critical Limb Ischemia, run by University Hospitals Cleveland Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Digital Subtraction Angiography
How many people
40 participants
Where
3 sitesUnited States
Study dates
16 Aug 2021to 9 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Tibial vessel involvement in patients with underlying peripheral artery disease and critical limb ischemia.

Who may be able to join

  • Age >18
  • Patients with presence of Rutherford IV-VI
  • Presence of ≥1 tibial artery involvement requiring endovascular treatment

Who cannot join

  • Patients who do not have tibial disease appropriate for intervention
  • Estimated glomerular filtration rate <30 mL/min not on hemodialysis

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University Hospitals Ahuja Medical Center

    Beachwood, Ohio, 44122

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

Other trials in United States

About this study

This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. Secondary comparison with intravascular ultrasound (IVUS) is undertaken when clinically feasible. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

Read the detailed description

This is a prospective, nonrandomized trial to investigate the adjunctive use of intravascular imaging in tibial vessel interventions. The evaluation of OCT is primarily to: (a) establish feasibility and reproducibility in below-the-knee vessels, (b) determine the optimal protocol imaging to produce the optimal clear image frame and clear image length, (c) provide detailed lesion characteristics of tibial disease, (d) assess for luminal gain post-intervention. Operator-determined sizing will be compared against University Hospitals Core Imaging Laboratory assessment of OCT, IVUS (when applicable), and quantitative vessel analysis (QVA).

Subjects will follow up per routine care with corresponding ankle-brachial index and toe-brachial index at 1, 3, 6, and 12 months or as clinically indicated. Wound and amputation data will be collected at the pre-procedural visit and with each subsequent visit. Wound care will be managed by our wound care associates in podiatry, vascular medicine, vascular surgery, or plastic surgery.

Being tested
Digital Subtraction Angiography
Medical subject headings
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

What participants receive

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

  • Digital Subtraction AngiographyDiagnostic test

    Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography

Study groups in NCT04748965
Study groupRoleWhat they receive
Tibial Vessel Involvement in Patients with peripheral artery disease and CLIThe primary goal is to establish a protocol for performing optimal OCT in below-the-knee vessels. OCT images will be analyzed for lesion characteristics, lesion sizing pre- and post-intervention. This will be analyzed against QVA and IVUS (latter if applicable).
Receives: Diagnostic Test: Digital Subtraction Angiography

What is being measured

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

  1. Standardized Technique for OCT Use in the Lower Limb

    To develop a protocolized, reproducible technique to maximize the Clear Image Length (CIL) on 75 mm pullbacks using 100% contrast in the tibial arteries. The goal is to compare intravascular ultrasound (IVUS) and optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

    Measured: 12 months

Secondary outcomes (13)

  1. Comparison of Percent Contrast

    CIL in 100% contrast versus 50% contrast/heparinized saline mixture

    Measured: 12 months

  2. Vessel Characteristics: Minimal Lumen Area

    minimal lumen area (mm^2)

    Measured: 12 months

  3. Vessel Characteristics: Reference Vessel Diameter

    reference vessel diameter (mm)

    Measured: 12 months

  4. Vessel Characteristics: Reference Vessel Area

    reference vessel area (mm^2)

    Measured: 12 months

  5. Vessel Characteristics: Percentage Stenosis

    percentage stenosis (%) on pre-intervention imaging

    Measured: 12 months

  6. Plaque Characteristics: Morphology

    Percentage composition of calcium, fibrous, or lipid plaque (%)

    Measured: 12 months

  7. Plaque Characteristics: Calcium Arc

    Calcium arc (degree)

    Measured: 12 months

  8. Plaque Characteristics: Calcium Depth

    depth of calcium (micron)

    Measured: 12 months

  9. Plaque Characteristics: Fibrous cap

    depth of fibrous cap (micron)

    Measured: 12 months

  10. Attenuation

    Measurement of attenuation coefficient (μ OCT) to quantify the strength of interaction of light and tissue

    Measured: 12 months

  11. Vessel Characteristics Following Intervention: Luminal Gain

    Post-intervention luminal gain (%), plaque modification, and dissections

    Measured: 12 months

  12. Vessel Characteristics Following Intervention: Plaque Modification

    Reduction in calcium depth (%) if atherectomy is performed

    Measured: 12 months

  13. Vessel Characteristics Following Intervention: Dissections

    Qualitative description of dissections seen on post-intervention imaging

    Measured: 12 months

Timeline

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

  1. First posted10 Feb 2021
  2. Study start16 Aug 2021
  3. Primary completion9 Jun 2024
  4. Study completion9 Jun 2024

Resources

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
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04748965
Sponsor's protocol ID
STUDY20210833
Acronym
iVEST
Status last verified
Apr 2025
First submitted
12 Dec 2020
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bezerra HG, Attizzani GF, Sirbu V, Musumeci G, Lortkipanidze N, Fujino Y, Wang W, Nakamura S, Erglis A, Guagliumi G, Costa MA. Optical coherence tomography versus intravascular ultrasound to evaluate coronary artery disease and percutaneous coronary intervention. JACC Cardiovasc Interv. 2013 Mar;6(3):228-36. doi: 10.1016/j.jcin.2012.09.017.

    PubMed 23517833

  • Witzenbichler B, Maehara A, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri EL Jr, Xu K, Parise H, Mehran R, Mintz GS, Stone GW. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation. 2014 Jan 28;129(4):463-70. doi: 10.1161/CIRCULATIONAHA.113.003942. Epub 2013 Nov 26.

    PubMed 24281330

  • Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.

    PubMed 26242713

  • Scoccianti M, Verbin CS, Kopchok GE, Back MR, Donayre CE, Sinow RM, White RA. Intravascular ultrasound guidance for peripheral vascular interventions. J Endovasc Surg. 1994 Sep;1:71-80. doi: 10.1583/1074-6218(1994)0012.0.CO;2.

    PubMed 9234107

  • Arthurs ZM, Bishop PD, Feiten LE, Eagleton MJ, Clair DG, Kashyap VS. Evaluation of peripheral atherosclerosis: a comparative analysis of angiography and intravascular ultrasound imaging. J Vasc Surg. 2010 Apr;51(4):933-8; discussion 939. doi: 10.1016/j.jvs.2009.11.034. Epub 2010 Jan 15.

    PubMed 20080002

  • Secco GG, Grattoni C, Parisi R, Oshoala K, Cremonesi A, Fattori R, Castriota F. Optical Coherence Tomography Guidance during Peripheral Vascular Intervention. Cardiovasc Intervent Radiol. 2015 Jun;38(3):768-72. doi: 10.1007/s00270-014-0868-3. Epub 2014 Mar 5. No abstract available.

    PubMed 24595662

  • Eberhardt KM, Treitl M, Boesenecker K, Maxien D, Reiser M, Rieger J. Prospective evaluation of optical coherence tomography in lower limb arteries compared with intravascular ultrasound. J Vasc Interv Radiol. 2013 Oct;24(10):1499-508. doi: 10.1016/j.jvir.2013.06.015. Epub 2013 Aug 17.

    PubMed 23962439

  • Paraskevopoulos I, Spiliopoulos S, Davlouros P, Karnabatidis D, Katsanos K, Alexopoulos D, Siablis D. Evaluation of below-the-knee drug-eluting stents with frequency-domain optical coherence tomography: neointimal hyperplasia and neoatherosclerosis. J Endovasc Ther. 2013 Feb;20(1):80-93. doi: 10.1583/12-4091.1.

    PubMed 23391087

  • Agarwal S, Sud K, Shishehbor MH. Nationwide Trends of Hospital Admission and Outcomes Among Critical Limb Ischemia Patients: From 2003-2011. J Am Coll Cardiol. 2016 Apr 26;67(16):1901-13. doi: 10.1016/j.jacc.2016.02.040. Epub 2016 Mar 21.

    PubMed 27012780

  • Ferraresi R, Mauri G, Losurdo F, Troisi N, Brancaccio D, Caravaggi C, Neri L. BAD transmission and SAD distribution: a new scenario for critical limb ischemia. J Cardiovasc Surg (Torino). 2018 Oct;59(5):655-664. doi: 10.23736/S0021-9509.18.10572-6. Epub 2018 May 22.

    PubMed 29786411

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Artery Disease and Critical Limb Ischemia, run by University Hospitals Cleveland Medical Center at 3 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 3 inclusion and 2 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Standardized Technique for OCT Use in the Lower Limb (time frame: 12 months). 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 NCT04748965, which also lists 10 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 2 May 2025.

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Imaging-Guided Vessel Sizing in the Tibial Arteries | AzTrials