NCT05868564

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jul 2023Jul 2027

First Submitted

Initial submission to the registry

March 7, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

4.1 years

First QC Date

March 7, 2023

Last Update Submit

May 19, 2023

Conditions

Peripheral Arterial Disease

Keywords

Atherectomydrug coated balloon

Outcome Measures

Primary Outcomes (2)

  • Peak Systolic Velocity Ratio (PSVR)

    Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)

    12-month

  • Freedom from major adverse limb events（MALEs）

    Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death

    12-month

Secondary Outcomes (5)

  • Technical success

    Immediately after endovascular treatment

  • Procedural success

    During the hospital stay

  • Primary sustained clinical improvement

    24-month

  • Quality of life score

    24-month

  • EuroQol five dimensions questionnaire (EQ 5D-5L) score

    24-month

Study Arms (2)

Atherectomy+Drug-coated balloon

EXPERIMENTAL

The lesion treated by atherectomy + UltrafreeTM drug-coated balloon.

Device: Atherectomy+Drug-coated balloon

Drug-coated balloon

ACTIVE COMPARATOR

The lesion treated by UltrafreeTM drug-coated balloon only.

Device: Drug-coated balloon

Interventions

Atherectomy+Drug-coated balloonDEVICE

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

Atherectomy+Drug-coated balloon
Drug-coated balloonDEVICE

drug-coated balloon only in the active comparator group.

Drug-coated balloon

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Meng Ye, M.D.

    Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ni Qihong, M.D.

CONTACT

+8615801900772niqihong1989@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2023

First Posted

May 22, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

CN(1)