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RecruitingNCT05894460Updated Aug 2, 2023

Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion

An observational study in Peripheral Arterial Disease, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by Xuanwu Hospital, Beijing · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
254
Ages
18 Years and older
Sex
All
01

Study summary

This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Femoral artery
  • Popliteal artery
  • Peripheral artery disease
  • Chocolate percutaneous transluminal angioplasty balloon
  • Drug-coated balloon
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 254 is above the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with femoropopliteal atherosclerotic occlusive disease

Inclusion criteria

  • Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease;
  • primary cases with no previous surgical treatment of the target lesion;
  • presence of at least one vessel with patency in the distal outflow tract;
  • survival >1 year.

Exclusion criteria

Exclusion Criteria:

  • planned stenting;
  • presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion;
  • combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure;
  • allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs;
  • ineffective recanalization attempts;
  • lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
254 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chocolate balloon

    Device: Chocolate balloon

  • Conventional ballon

    Device: Chocolate balloon

Interventions

  • DeviceChocolate balloon

    Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty

06

What researchers measure

Primary outcomes

  1. Primary patency

    No occlusion or restenosis (\>50%) of the target vessel in the treated segment during follow-up and no further intervention is required.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital
    Beijing, None Selected 100053, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05894460
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
Jun 8, 2023
Start date
Jun 27, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 2, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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