Eluvia DES for the Patients with Femoropopliteal Artery L... | NCT05522218

Studies
Eluvia DES for the Patients with Femoropopliteal Artery Lesions.

NCT05522218

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Recruiting

Last Update Posted

Sep 27, 2024Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Vascular Diseases
Stent Complication

Interventions

Eluvia drug eluting stent

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Actual

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Aug 24, 2022

First Submission Date that Met QC Criteria

Aug 28, 2022

First Posted Date

Aug 30, 2022Actual

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

Sep 25, 2024

Last Update Posted Date

Sep 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ziheng Wu, MD, Associated chief physician, First Affiliated Hospital of Zhejiang UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.

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

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eluvia drug eluting stent	Device	Eluvia drug eluting stent for peripheral arterial disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change of Rutherfor classification	Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months	24 months
F-TLR	free of target vascular reconstruction	24 months
limb salvage rate	Proportion of patients without ambutation	24 months

Secondary Outcomes

Measure	Description	Time Frame
Technical success rate	Percentage of patients with successful endovascular treatment without postoperative complications	1 month
the patency target lesion	Restenosis was defined as PSVR > 2.4 as determined by vascular ultrasonography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rutherford Stage 2-5.
At least 90% stenosis or occlusion of the femoropopliteal artery.
Eluvia stents are used for target lesions.
Agree and sign the informed consent form

Exclusion Criteria:

Life expectancy is less than 1 year.
Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened.
Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life.
Patients with in-stent restenosis of the femoral popliteal artery.
Patients with acute arterial thrombosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

peripheral arterial disease patients implanted with Eluvia stent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Zhejiang University	Recruiting	Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

After recruitment, data will be shared after 2 years of follow-up

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided