Femoropopliteal Artery Disease
Conditions
Keywords
Femoropopliteal artery disease, drug-coated balloon, angioplasty, atherectomy
Brief summary
* Prospective, multi-center, randomized, controlled comparison study * A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (\>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions. * Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year. * Patients will be followed clinically for 2 years after the procedure.
Interventions
PROCEDURECombination therapy of atherectomy and DCB
The target lesion in femoropopliteal artery will be treated with atherectomy folloewd by DCB. The choice of atherectomy devices (HawkOne, Jectstream, or Rotarex)and DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.
PROCEDUREDCB alone
The target lesion in femoropopliteal artery will be treated with DCB. The choice of DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 19 years or older 2. Symptomatic peripheral artery disease: * Moderate or severe claudication (Rutherford category 2 or 3) * Critical limb ischemia (Rutherford category 4 or 5) 3. Femoropopliteal artery disease (stenosis \> 50%) with one of following complex lesion characteristics: - long lesion (\>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4) 4. Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone 5. Patients with signed informed consent
Exclusion criteria
1. Acute critical limb ischemia 2. Severe critical limb ischemia (Rutherford category 6) 3. Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions 4. Age \> 85 years 5. Severe hepatic dysfunction (\> 3 times normal reference values) 6. Significant thrombocytopenia, anemia, or known bleeding diathesis 7. LVEF \< 35% or clinically overt congestive heart failure 8. Pregnant women or women with potential childbearing 9. Life expectancy \<1 year due to comorbidity 10. Previous bypass surgery in the target femoropopliteal artery 11. Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 months post treatment | Primary patency is defined as absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography |
Countries
South Korea
Contacts
Primary ContactYoung-Guk Ko, MD, PhD
Outcome results
None listed