Intravascular Ultrasound for Peripheral Artery Disease Revascularization

NCT06979284 | Not Yet Recruiting DMC

• 1 other identifier: 5251
• Study Type: interventional
• Target: 772
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who have CLTI and are undergoing percutaneous revascularization.

Conditions

Peripheral Arterial Disease(PAD); Chronic Limb Threatening Ischemia; Intravascular Ultrasound; Major Adverse Limb Events; Restenosis

Outcome Measures

Primary Outcomes (1)

• Time-to-first occurrence of MALE

  Defined as unplanned above ankle amputation of the index limb or clinically driven target lesion revascularization, or target-lesion binary restenosis, defined as \> 50% stenosis on imaging throughout follow-up.

  From date of randomization until the date of first unplanned above ankle amputation of the index limb, clinically driven target lesion revascularization or target-lesion binary restenosis, assessed up to a maximum of 5 years.

Secondary Outcomes (10)

• The composite of all-cause mortality, MALE, or target-lesion binary restenosis

  From date of randomization until the date of death, MALE, or target lesion binary restenosis, assessed up to a maximum of 5 years.

• MALE

  From date of randomization, assessed up to a maximum of 5 years.

• All-cause mortality

  From date of randomization, assessed up to a maximum of 5 years.

• Unplanned above-ankle amputation of the index limb

  From date of randomization, assessed up to a maximum of 5 years.

• Clinically-driven target lesion revascularization

  From date of randomization, assessed up to a maximum of 5 years.

Study Arms (2)

Intravascular Ultrasound - guided strategy

ACTIVE COMPARATOR

Percutaneous revascularization will be performed using intravascular ultrasound.

Procedure: IVUS-guided strategy

Angiography - guided strategy

NO INTERVENTION

A standard-of-care percutaneous revascularization will be performed without using intravascular ultrasound.

Interventions

IVUS-guided strategy PROCEDURE

Percutaneous revascularization will be performed using intravascular ultrasound. The operators will follow instructions to modify arteries hardened by calcium and use IVUS to optimize the equipment (balloon and stents) used to unblock the artery.

Intravascular Ultrasound - guided strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with lower extremity PAD manifesting as CLTI:
• a. CLTI is defined as ischemic rest foot pain, nonhealing wounds, or gangrene present for at least two weeks and that is attributable to objectively proven arterial occlusive disease, compatible with Rutherford class 4, 5 or 6, with the following supporting hemodynamic criteria1: i. For ischemic rest pain (Rutherford category 4): Ankle systolic pressure \< 40mmHg, toe pressure \< 30mmHg, or flat-line transtarsal pulse volume recording, OR ii. For tissue loss (Rutherford category 5, 6): Ankle systolic pressure \< 60 mmHg, toe pressure of \< 40mmHg, or flat-line transtarsal volume recording, AND
• Scheduled to undergo percutaneous revascularization, AND
• Informed consent
• Imaging evidence of an obstructive or occluded lesion (\> 70%) in the infraiguinal circulation (e.g. femoral, popliteal, or infrapopliteal circulation) using angiography, ultrasound, computed tomography, or magnetic resonance imaging.
• An infrapopliteal lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with a vessel diameter of \> 2.5mm by investigator visual assessment.
• The distal margin of the most distal target lesion must be located \> 10 cm proximal to the proximal margin on the ankle mortise. The vessel segment distal to the most distal target lesion must be patent all the way to the ankle, with no obstructive lesion (\>50% stenosis).

You may not qualify if:

• The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-up requirements.
• The presence of any medical conditions precluding percutaneous revascularization
• The subject has previously had or requires surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity.
• The subject is bedridden or unable to walk (with assistance is acceptable).
• Life expectancy \< 12 months
• Age \< 18 years
• Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
• Planned above-ankle amputation of the index limb within four weeks of the index procedure.
• Obstructive supra-inguinal "inflow" (\>70% stenosis) which is not planned to be treated during index procedure or within 30 days of the index procedure.
• The subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or the subject has had a major amputation to the contralateral extremity \< 1 year before the index procedure and is not independently walking.
• Extensive tissue loss that is salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations.
• Osteomyelitis that extends proximal to the metatarsal heads
• Gangrene involving the plantar skin of the forefoot, midfoot or heel
• Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the f forefoot, midfoot, or heel
• Full-thickness heel ulcer

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

CLARITY Project Office

CONTACT

905-521-2100; CLARITY@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, international, prospective, randomized, open, blinded endpoint (PROBE) parallel trial.

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 18, 2025

Record last verified: 2025-04