BridgeMD
Compares treatment options for Femoropopliteal Artery Disease
Official title Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease
ClinicalTrials.gov ID: NCT05307263
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 85
You may be able to join if
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- Femoropopliteal artery disease (stenosis \> 50%) with one of following complex lesion characteristics: - long lesion (\>150 mm), in-stent restenosis...
You likely can't join if
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
- Age \> 85 years
- Severe hepatic dysfunction (\> 3 times normal reference values)
- Significant thrombocytopenia, anemia, or known bleeding diathesis
See the full eligibility criteria
- Age 19 years or older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5)
- 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)
- Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
- Patients with signed informed consent
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
- Age \> 85 years
- Severe hepatic dysfunction (\> 3 times normal reference values)
- Significant thrombocytopenia, anemia, or known bleeding diathesis
- LVEF \< 35% or clinically overt congestive heart failure
- Pregnant women or women with potential childbearing
- Life expectancy \<1 year due to comorbidity
- Previous bypass surgery in the target femoropopliteal artery
- Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.