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NCT05868564 | NOT YET RECRUITING | Peripheral Arterial Disease

Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
Sponsor:

RenJi Hospital

Brief Summary:

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.

Condition or disease

Peripheral Arterial Disease

Intervention/treatment

Atherectomy+Drug-coated balloon

Drug-coated balloon

Phase

NA

Detailed Description:

This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion\>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions
Actual Study Start Date : 2023-07-01
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2027-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Subject must be between 18 and 85 years old;
  • 2. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
  • 3. 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;
  • 4. Patent distal popliteal artery and at least one patent distal runoff;
  • 5. Willing to comply with the follow-up evaluation;
  • 6. Written informed consent prior to any study procedures.
Exclusion Criteria
  • 1. Women during pregnancy and lactation, or patients with baby planning;
  • 2. Life expectancy\<2 years;
  • 3. Target lesion/vessel with in-stent restenosis
  • 4. Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy \<12 months
  • 5. Subjects s who are currently participating in other interventional drug or device trials;
  • 6. Angiographic evidence of thrombus within the target vessel
  • 7. Subjects have a history of stroke within 3 months;
  • 8. Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
  • 9. Concomitant Renal failure with a serum creatinine\>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions

Location Details

NCT05868564

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How to Participate

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Locations

Not yet recruiting

China, Shanghai

Renji Hospital

Shanghai, Shanghai, China, 200127