Clinical trial NCT06234280: Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Official title: Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions
Moderate or Severe Claudication (Rutherford Category 2 or 3)
Critical Limb Ischemia (Rutherford Category 4 or 5)
Keywords: Peripheral artery disease
femoropopliteal
drug-eluting stent
restenosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic peripheral artery disease with femoropopliteal lesions:

* Moderate or severe claudication (Rutherford category 2 or 3)
* Critical limb ischemia (Rutherford category 4 or 5) Age: ≥19 years, but not older than 85 years

Brief summary: * Prospective, multi-center single-arm observational study
* A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
* Patients will be followed clinically for 24 months after the procedure.
* An imaging study (duplex ultrasound, CT or catheter-based angiography) follow-up according to participating hospital's protocol will be performed at 12 months.
* Ankle-brachial index, symptom status and presence of stent fracture will be evaluated at 12 months.

Detailed description: • Prospective, multi-center single-arm observational study

Screening (day 0):

1. Medical history and demography of the patient reviewed
2. Inclusion/exclusion eligibility will be checked
3. Physical examination (Height, weight)
4. Laboratory test

   * BUN, eGFR, Cr.
   * Hb, WBC, platelet
   * Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
5. Ankle-brachial index
6. Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)
7. Medication

Enrollment (day 0):

1) Written consent

Post PTA (Day 1 \~3):

1. Adverse event
2. Ankle-brachial index
3. Laboratory test:

   * BUN, eGFR, Cr.
   * Hb, WBC, platelet
4. Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days)

1) Symptom: Rutherford class 2) Laboratory test:

* BUN, eGFR, Cr.
* Hb, WBC, platelet 3) Concomitant medication 4) Adverse event Visit 2 (post-PTA 6 months ± 30 days)

  1. Symptoms: Rutherford class
  2. Ankle-brachial index
  3. Concomitant medication
  4. Adverse event Visit 3 (post-PTA 12 months ± 60 days)

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  1. Symptoms: Rutherford class
  2. Ankle-brachial index
  3. Duplex ultrasound, CT, or catheter angiography
  4. Biplane radiograph of femur for evaluation of stent fracture
  5. Laboratory test
* BUN, eGFR, Cr.
* Hb, WBC, platelet
* Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) 6)Concomitant medication 7) Adverse event Visit4 (post-PTA 24 months ± 60 days)

  1. Symptom: Rutherford category
  2. Adverse events

Eligibility criteria: Inclusion Criteria:

1. Age 19 years of older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4-5)
3. Femoropopliteal artery lesions with stenosis \> 50%
4. ABI \< 0.9 before treatment
5. Patents treated with ELUVIA stent for femoropopliteal artery disease
6. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age \> 85 years
7. Severe hepatic dysfunction (\> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
12. Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Primary outcomes:
measure: Clinical patency
timeFrame: at 24 months
Secondary outcomes:
measure: Ankle-brachial index
timeFrame: at 12 and 24 months
measure: Ruthford category
timeFrame: at 12 and 24 months
measure: target lesion revascularization
timeFrame: at 12 and 24 months
measure: stent fracture rate
timeFrame: at 12 and 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
name: Young-Guk Ko, MD
role: PRINCIPAL_INVESTIGATOR
References: