Peripheral Arterial DiseaseNCT05894460
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion
An observational study of Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Chocolate balloon
- Type of treatment
- Medical device
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with femoropopliteal atherosclerotic occlusive disease
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, None Selected, 100053
Zhu Tong, 13522419980, tongzhuxw@163.com
About this study
Official title: Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Chocolate balloon
- Keywords
- Femoral artery, Popliteal artery, Peripheral artery disease, Chocolate percutaneous transluminal angioplasty balloon, Drug-coated balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chocolate balloonDevice
Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Chocolate balloon | Not described Receives: Device: Chocolate balloon | |
| Conventional ballon | Not described Receives: Device: Chocolate balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
No occlusion or restenosis (>50%) of the target vessel in the treated segment during follow-up and no further intervention is required.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start27 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894460
- Sponsor's protocol ID
- Chocolate-FP
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05894460
- Acronym / sponsor ID
- Chocolate-FP
- Conditions
- Peripheral Arterial Disease
- Keywords
- Femoral artery, Popliteal artery, Peripheral artery disease, Chocolate percutaneous transluminal angioplasty balloon, Drug-coated balloon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chocolate balloon | – | Device: Chocolate balloon |
| Conventional ballon | – | Device: Chocolate balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with femoropopliteal atherosclerotic occlusive disease
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chocolate balloonVascular preparation with chocolate balloons prior to drug-coated balloon angioplasty | Device | Chocolate balloon, Conventional ballon |
Primary outcome
Primary patency
Time frame: 12 months
No occlusion or restenosis (>50%) of the target vessel in the treated segment during follow-up and no further intervention is required.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.