Clinical trial NCT03505931: Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
Official title: Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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: 2018-04-23
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 12 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: Enrollment (day 0):

1) Written consent

Post PTA (Day 1 \~3):

1. Symptom: Rutherford class
2. Adverse event
3. Ankle-brachial index
4. Laboratory test: - eGFR, Cr, ALT, AST

   * Hb, WBC, platelet
5. Concomitant medication

Regular Follow-up Visits

Visit 1 (post-PTA 30±14 days):

1. Symptom: Rutherford class
2. Physical examination
3. Concomitant medication
4. Adverse event
5. Laboratory test:

   * AC glucose, eGFR, Cr, ALT, AST
   * Hb, WBC, platelet
   * Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
   * HbA1c in case of DM
   * hsCRP

Visit 2 (post-PTA 6 months ± 30 days):

1. Symptoms: Rutherford class
2. Physical examination
3. Ankle-brachial index
4. Concomitant medication
5. Adverse event

Visit 3 (post-PTA 12 months ± 30 days): (Mandatory)

1. Symptoms: Rutherford class
2. Physical examination
3. Ankle-brachial index
4. Duplex ultrasound, CT, or catheter angiography
5. Concomitant medication
6. Adverse event 7) Biplane radiograph of femur for evaluation of stent fracture 8) Laboratory test: - AC glucose, eGFR, Cr, ALT, AST

   * Hb, WBC, platelet
   * Lipid level (total cholesterol, LDL-C,triglyceride, HDL-C)
   * HbA1c in case of DM
   * hsCRP

Eligibility criteria: Inclusion Criteria:

* Age 19 years of older
* Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) and Critical limb ischemia (Rutherford category 4-5)
* Femoropopliteal artery lesions with stenosis \> 50%
* ABI \< 0.9 before treatment
* Patents treated with ELUVIA stent for femoropopliteal artery disease
* Patients with signed informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Primary patency
timeFrame: at 12 months
Secondary outcomes:
measure: Ankle-brachial index
timeFrame: at 12 months
measure: Ruthford category
timeFrame: at 12 months
measure: target lesion revascularization
timeFrame: at 12 months
measure: stent fracture rate
timeFrame: at 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References: