IntravasCular Imaging-Guided Versus AngiogRaphy-GUided Drug-Eluting Stent Implantation for Fermoropopliteal Artery Disease

NCT05805280 | Completed DMC

• 1 other identifier: 2019-1514
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

Objectives: 1) To evaluate the feasibility of using intravascular ultrasound to assess lesion morphology, select an appropriate stent size and landing zone 2) To compare the primary patency rates after intra vascular imaging-guided versus angiography-guided stent implantation for the treatment of fermoropopliteal artery segment lesions. Hypothesis: One of the key determinants of the device failure is inappropriate landing zone, selection of smaller stent relative to the reference vessel diameter, and lack of high-pressure post-dilatation in a necessary post-stent segment. Therefore, intravascular ultrasound-guided selection of appropriate landing zone, stent size and balloon size for high pressure post-dilation may maximize the benefits of stent use and improve patency duration. the investigators hypothesize that intravascular ultrasound-guided stent implantation is superior to angiography-guided stent implantation with respect to 12 months primary patency in patients with significant femoropopliteal disease

Conditions

Femoropopliteal Disease

Outcome Measures

Primary Outcomes (3)

• patency at 12 months after treatment

  peak systolic velocity ratio 2.4 or lower as assessed by the duplex ultrasound, in the absence of clinically driven target lesion revascularization or bypass of the target lesion.

  12 month after randomization

• Number of procedure related death

  procedure related death through 30 days post-procedure

  30 Days post procedure

• Number of major amputation of the target limb or target-lesion revascularization

  major amputation of the target limb through 12 months, or target-lesion revascularization through 12 months

  12 month after randomization

Secondary Outcomes (3)

• technical success

  within 24 hours

• procedural success

  within 24 hours

• Rutherford category score

  12 month after randomization

Study Arms (2)

intravascular ultrasound-guided group

EXPERIMENTAL

In the intravascular ultrasound-guided group, intravascular ultrasound will be either automatically (1 mm/sec) or manually (5-10 mm/sec) pulled back at a constant speed according to the lesion length. Stent size and length are selected by information acquired from on-line intravascular ultrasound examination, and adjunct high-pressure dilation is performed to achieve stent optimization based on the intravascular ultrasound finding

Device: intravascular ultrasound-guided group

angiography-guided group

ACTIVE COMPARATOR

In the angiography-guided group, stent size and length are chosen by visual estimation, and adjunctive high-pressure dilation is performed if an optimal result, defined as angiographic residual diameter stenosis of less than 30% by visual estimation and the absence of angiographically detected dissection, , was not achieved

Device: angiography-guided group

Interventions

intravascular ultrasound-guided group DEVICE

intravascular ultrasound use

intravascular ultrasound-guided group

angiography-guided group DEVICE

angiography-guided use

angiography-guided group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women at least 20 years up to 85 years of age
• Intermittent claudication or tissue loss suitable for elective endovascular intervention (Rutherford category 2,3,4, or 5)
• Significant native superficial femoral or proximal popliteal artery lesions suitable for stent implantation. Restenotic lesions can be enrolled at least 12-month after the index procedure uding plain balloon or drug-coated balloon.
• Total lesion length of 30 to 220 mm
• Reference vessel diameter of 4 - 6 mm
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

You may not qualify if:

• Existence of a stent in the target vessel
• Previous use of atherectomy device in the target vessel
• Use of drug-coated balloon in the target vessel within 12-month
• Untreatable significant stenosis or occlusion (diameter stenosis ≥70%) in all 3 infrapopliteal arteries (patient can be enrolled if at least 1 patent outflow artery to the ankle (diameter stenosis \<50%) can be achieved by treatment during the index procedure)
• A known intolerance or contraindication to antiplatelet drugs (aspirin or clopidogrel)
• Unwillingness or inability to comply with the procedures described in this protocol.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (8)

Inje University Busan Paik Hospital

Busan, South Korea

Location

Veterans Hospital

Daegu, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Severance Cardiovascular Hospital

Seoul, South Korea

Location

Veterans Health Service Medical Center

Seoul, South Korea

Location

Ajou University Medical Center

Suwon, South Korea

Location

Study Officials

• Pil Hyung Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Part of cardiology, Principal Investigator, associate professor

Model Details: Enrolled patients will be randomized at a ratio 1:1 to two treatment arms by a computer-generated randomization sequence with a permutated block size 4. a) intravascular ultrasound-guided group or b) Angiography-guided group

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 7, 2023
• Study Start: November 27, 2020
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)