Constrained Balloon Combined With Drug-coated Balloon Ang... | NCT05894460

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

NCT05894460

Sponsor

Xuanwu Hospital, Beijing

Status

Unknown status

Last Update Posted

Aug 2, 2023Actual

Enrollment

254Estimated

Phase

Not provided

Conditions

Peripheral Arterial Disease

Interventions

Chocolate balloon

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

May 30, 2023

First Submission Date that Met QC Criteria

May 30, 2023

First Posted Date

Jun 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2023

Last Update Posted Date

Aug 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

254Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chocolate balloon			Device: Chocolate balloon
Conventional ballon			Device: Chocolate balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chocolate balloon	Device	Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty	Chocolate balloon Conventional ballon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with femoropopliteal atherosclerotic occlusive disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital	Recruiting	Beijing	None Selected	100053	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided