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Not yet recruiting NCT05868564

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

No phase Interventional Peripheral Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atherectomy+Drug-coated balloon, Drug-coated balloon.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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.

Interventions

  • Device Atherectomy+Drug-coated balloon
    Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group
  • Device Drug-coated balloon
    drug-coated balloon only in the active comparator group.

Primary outcome measures

  • Peak Systolic Velocity Ratio (PSVR) [Time frame: 12-month]
  • Freedom from major adverse limb events（MALEs） [Time frame: 12-month]
Secondary outcome measures (5)
  • Technical success [Time frame: Immediately after endovascular treatment]
  • Procedural success [Time frame: During the hospital stay]
  • Primary sustained clinical improvement [Time frame: 24-month]
  • Quality of life score [Time frame: 24-month]
  • EuroQol five dimensions questionnaire (EQ 5D-5L) score [Time frame: 24-month]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Women during pregnancy and lactation, or patients with baby planning;
  • Life expectancy<2 years;
  • Target lesion/vessel with in-stent restenosis
  • 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;
  • Angiographic evidence of thrombus within the target vessel
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital — Shanghai

Identifiers

NCT: NCT05868564 · The DEFINITIVE LL Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗