NCT07406308

Brief Summary

This study aims to compare mid-to long-term outcomes of paclitaxel-coated balloon angioplasty with adjunctive debulking versus paclitaxel-coated balloon angioplasty alone for the treatment of chronic femoropopliteal artery diseases.

Trial Health

63
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Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for early_phase_1

Timeline
25mo left

Started Apr 2026

Typical duration for early_phase_1

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 Progress2%
Apr 2026May 2028

First Submitted

Initial submission to the registry

February 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

February 5, 2026

Last Update Submit

February 5, 2026

Conditions

Femoropopliteal Artery Occlusion

Keywords

Femoropopliteal Artery OcclusionDrug-Coated Balloondebulking procedures

Outcome Measures

Primary Outcomes (1)

  • 1-year primary patency rate

    1 year

Secondary Outcomes (1)

  • free from clinical-driven target lesion revascularization

    1 year

Study Arms (2)

DCB

ACTIVE COMPARATOR

Participants in this group will be received drug-coated balloon angioplasty

Device: paclitaxel-coated balloon angioplasty

DCB+DP

EXPERIMENTAL

Participants in this group will be received drug-coated balloon angioplasty with debulking procedures.

Device: paclitaxel-coated balloon angioplasty with debulking procedures

Interventions

paclitaxel-coated balloon angioplastyDEVICE

No debulking procedures were taken

DCB
paclitaxel-coated balloon angioplasty with debulking proceduresDEVICE

The patient underwent DCB treatment along with debulking procedures (such as laser or plaque rotational atherectomy, etc.).

DCB+DP

Eligibility Criteria

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

You may qualify if:

  • Subject age 18-85yrs.
  • Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
  • Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
  • Rutherford category 2-5.
  • Subject has atherosclerotic de novo, non-stented restenotic, or in-stent restenotic/occlusive lesions in the superficial femoral artery (SFA) and/or popliteal artery (P1 segment).
  • Patent inflow artery with stenosis \<30% by visual estimation (or by core lab assessment if available) and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis).
  • A guidewire has successfully traversed the target treatment segment.

You may not qualify if:

  • Subject presents with acute arterial embolism or thrombosis requiring thrombectomy or thrombolysis for limb ischemia.
  • Subject has arterial occlusion caused by thromboangiitis obliterans (Buerger's disease) or other forms of immune-mediated vasculitis.
  • Subject has undergone surgery on the target vessel within the past 3 months, or has experienced repeated failures of endovascular therapy and is deemed unsuitable for further endovascular intervention.
  • Subject has an uncontrolled thrombophilia or hypercoagulable state.
  • Subject has a severe systemic disease (e.g., malignancy) with a life expectancy of less than 1 year.
  • Subject has contraindications or intolerance to antiplatelet/anticoagulant medications, such as aspirin, clopidogrel, or heparin.
  • Subject is pregnant or breastfeeding.
  • Subject meets one or more of the following conditions: chronic renal insufficiency (SCr ≥ 2.5 mg/dL) or on regular dialysis; cardiovascular or cerebrovascular surgery within the past 1 month; or severe sequelae from a major stroke.
  • Subject has a known allergy to nitinol alloy, paclitaxel, or contrast agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Central Study Contacts

Leng Ni, MD

CONTACT

86-1069152501nileng@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective, non-randomized, controlled cohort study. 1. Eligible patients with chronic femoropopliteal artery occlusions will be assigned to one of the two treatment groups based on a combination of clinical assessment, anatomical factors, and patient preference: (1) the Combination Therapy Group (paclitaxel-coated balloon angioplasty with adjunctive atherectomy/debulking), or (2) the DCB-Alone Group (paclitaxel-coated balloon angioplasty alone). 2. Treatment allocation is not randomized. Patients in both groups will be prospectively followed and their outcomes compared to assess the relative efficacy and safety of the two treatment strategies.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 12, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

March 20, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

February 12, 2026

Record last verified: 2026-01

Locations

CN(1)