Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05868564, who can take part
Where in China
- RenJi HospitalShanghai, ChinaContact: Ni Qihong, M.D.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT05868564
- Record updated
- 22 May 2023
- Original description
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.Read full original descriptionShow less
Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.
Inclusion: Subject must be between 18 and 85 years old; Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5; Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization; Patent distal popliteal artery and at least one patent distal runoff; Willing to comply with the follow-up evaluation; Written informed consent prior to any study procedures.
Exclusion: Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months; Subjects s who are currently participating in other interventional drug or device trials; Subjects have a history of stroke within 3 months; Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks; Concomitant Renal failure with a serum creatinine>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents; Life expectancy<2 years; Women during pregnancy and lactation, or patients with baby planning; Target lesion/vessel with in-stent restenosis; Angiographic evidence of thrombus within the target vessel.