NCT05894460

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

June 27, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 2, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

May 30, 2023

Last Update Submit

July 30, 2023

Conditions

Peripheral Arterial Disease

Keywords

Femoral arteryPopliteal arteryPeripheral artery diseaseChocolate percutaneous transluminal angioplasty balloonDrug-coated balloon

Outcome Measures

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.

    12 months

Study Arms (2)

Chocolate balloon

Device: Chocolate balloon

Conventional ballon

Device: Chocolate balloon

Interventions

Chocolate balloonDEVICE

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

Chocolate balloonConventional ballon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with femoropopliteal atherosclerotic occlusive disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, None Selected, 100053, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 8, 2023

Study Start

June 27, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 2, 2023

Record last verified: 2023-05

Locations

CN(1)