IVUS Guidance in BTK Interventions

NCT07731997 | Not Yet Recruiting DMC

• 1 other identifier: 20251224R
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 4

Brief Summary

Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb. It is often treated with endovascular therapy (EVT), a minimally invasive procedure that opens the blocked artery, but the artery frequently narrows or closes again afterward. These procedures are usually guided by X-ray pictures taken with dye (angiography). Intravascular ultrasound (IVUS) is an imaging tool that uses a small catheter inside the artery to give a more detailed view of the vessel, which may help doctors open it more completely. It is not yet clear whether adding IVUS improves results below the knee. This study is testing whether guiding treatment with IVUS plus angiography keeps the artery open better than angiography alone. Adults aged 18 or older with CLTI who are having endovascular therapy for a blocked artery below the knee may take part. Participants are assigned by chance to be treated with either both imaging methods or angiography alone, and are followed for 12 months. The main question is how well the treated artery stays open at 6 months; researchers will also compare repeat procedures, amputation, complications, wound healing, survival, and quality of life.

Conditions

Chronic Limb-Threatening Ischemia

Keywords

IMAGE-BTK; Chronic limb-threatening ischemia; Peripheral artery disease; Endovascular therapy; Intravascular ultrasound; Primary patency

Outcome Measures

Primary Outcomes (1)

• Primary patency at 6 months

  Freedom from clinically driven target lesion revascularization (CD-TLR), total occlusion of the target vessel, or binary restenosis of the target lesion. Binary restenosis is defined as a peak systolic velocity ratio \>2.0 on duplex ultrasound. Reported as the proportion of participants meeting all three criteria.

  6 months after the index procedure

Secondary Outcomes (18)

• Major amputation of the study limb

  12 months

• Major adverse limb events (MALE)

  12 months

• Composite freedom from limb events

  12 months

• Wound healing (Rutherford class 5 participants)

  1, 3, 6, 9, and 12 months

• Time to complete wound healing (Rutherford class 5 participants)

  From the index procedure to 12 months

Study Arms (2)

IVUS + Angiography-guided EVT

EXPERIMENTAL

Procedure: Intravascular ultrasound-guided EVT

Angiography-guided EVT

ACTIVE COMPARATOR

Procedure: Angiography-guided EVT

Interventions

Intravascular ultrasound-guided EVT PROCEDURE

Endovascular therapy of the below-the-knee artery is guided by intravascular ultrasound (IVUS) imaging in addition to X-ray angiography, with IVUS used to assess the lesion, size and select devices, optimize treatment, and confirm the final result.

IVUS + Angiography-guided EVT

Angiography-guided EVT PROCEDURE

Endovascular therapy of the below-the-knee artery is guided by X-ray angiography with contrast dye alone, without the use of intravascular ultrasound, to assess the lesion, size and select devices, and judge the final result.

Angiography-guided EVT

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Documented chronic limb-threatening ischemia, meeting the following criteria according to guidelines(13):
• Presence of ischemic symptoms compatible with CLTI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford classes 4-5 AND
• Imaging evidence within the past 12 months showing atherosclerotic PAD, including CTA, MRA, angiography or duplex ultrasound AND
• Ankle-Brachial Index (ABI) ≤0.80 or Toe-Brachial Index (TBI) ≤0.60 for patients who never underwent revascularization; ABI ≤0.85 or TBI ≤0.65 for those with history of prior revascularization procedures OR
• Ischemic rest pain alone (Rutherford class 4) with ankle systolic pressure \<50 mmHg, toe pressure of \<30 mmHg, transcutaneous PO2 of \<30 mmHg, or flat-line transtarsal pulse volume recording OR
• Tissue loss with or without ischemic rest pain (Rutherford class 5) with ankle systolic pressure \<70 mmHg, toe pressure of \<50 mmHg, transcutaneous PO2 of \<30 mmHg, or flatline transtarsal pulse volume recording
• Absence of occlusive upstream disease, defined by the following:
• Demonstrated vascular patency from the aorta to the second segment of the popliteal artery (P2), either by angiography, duplex ultrasound, CTA or MRA within the last 7 days prior to randomization
• In patients who underwent prior treatment for upstream disease, there are no restrictions in treatment modalities received as long as patency is demonstrated as previously defined
• If upstream disease is planned to be treated in the same index procedure, technically successful treatment of the upstream vessels must be achieved before randomization, defined as less than 30% residual stenosis and no flow-limiting dissections
• Informed Consent:
• Demonstrated ability and willingness to adhere to the study protocol and provide written informed consent

You may not qualify if:

• Age \<18 years
• Asymptomatic or mild disease: patients who underwent revascularization for disease graded Rutherford classes 0-3
• Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening
• Patient with a history of prior major (above-the-ankle) amputation of the study limb
• Unable to tolerate any antiplatelet agent or with severe bleeding diathesis
• Clinical signs of active, uncontrolled, severe limb infection or septicemia, defined as fever exceeding 38.5°C, a white blood cell count above 15,000 cells/µL, or hypotension, at the time of screening (this does not include osteomyelitis confined to the phalanges or metatarsal heads or foot cellulitis treatable with IV antibiotics at the time of revascularization)
• Acute coronary syndrome or acute stroke within 30 days of screening
• Active hepatitis or severe liver cirrhosis (Child Pugh C)
• Advanced CKD (defined with eGFR\<30 mL/min/1.73m2) or end-stage renal disease
• Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
• Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s) that has not yet reached its primary endpoint
• Life expectancy \<1 year

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead
• National Taiwan University Hospital: collaborator
• Chi Mei Medical Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (4)

Chi Mei Medical Center

Tainan, 710, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

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

Study Officials

• Donna SH Lin, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna SH Lin, MD

CONTACT

+886-2-2833-2211; donna.lin24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)