Vascular DiseasesNCT05522218
Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
An observational study of Vascular Diseases and Stent Complication, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Diseases, Stent Complication
- What is being tested?
- Eluvia drug eluting stent
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: peripheral arterial disease patients implanted with Eluvia stent
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Ziheng Wu, PhD, 0571-87236745, wuziheng@zju.edu.cn
About this study
Official title: Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
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.
- Conditions
- Vascular Diseases, Stent Complication
- Being tested
- Eluvia drug eluting stent
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eluvia drug eluting stentDevice
Eluvia drug eluting stent for peripheral arterial disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Rutherfor classification
Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months
Measured: 24 months
F-TLR
free of target vascular reconstruction
Measured: 24 months
limb salvage rate
Proportion of patients without ambutation
Measured: 24 months
Secondary outcomes (7)
Technical success rate
Percentage of patients with successful endovascular treatment without postoperative complications
Measured: 1 month
the patency target lesion
Restenosis was defined as PSVR > 2.4 as determined by vascular ultrasonography
Measured: 24 months
mortality rate
the propotion of death
Measured: 24 months
the life quality change
Amount by Vas-Qol questionare between perioperation and 24month postoperation
Measured: 24 months
the life quality change
Amount by EQ-5D5L questionare between perioperation and 24month postoperation
Measured: 24 months
Economics Evaluation
Cumulative hospitalization expenses related to treatment within 24 months
Measured: 24 months
Wound Healing Evaluation
If there is an ulcer wound, evaluate the ulcer wound healing at 24 months after surgery and before treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziheng Wu, MD, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522218
- Sponsor's protocol ID
- IIT20220166B-X1
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After recruitment, data will be shared after 2 years of follow-up
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
- ClinicalTrials.gov ID
- NCT05522218
- Acronym / sponsor ID
- IIT20220166B-X1
- Conditions
- Vascular Diseases, Stent Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Aug 2022 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- peripheral arterial disease patients implanted with Eluvia stent
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Eluvia drug eluting stentEluvia drug eluting stent for peripheral arterial disease | Device | – |
Primary outcome
The change of Rutherfor classification
Time frame: 24 months
Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months
F-TLR
Time frame: 24 months
free of target vascular reconstruction
limb salvage rate
Time frame: 24 months
Proportion of patients without ambutation
7 secondary outcomes
Technical success rate
Time frame: 1 month
the patency target lesion
Time frame: 24 months
mortality rate
Time frame: 24 months
the life quality change
Time frame: 24 months
the life quality change
Time frame: 24 months
Economics Evaluation
Time frame: 24 months
Wound Healing Evaluation
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Undecided. After recruitment, data will be shared after 2 years of follow-up
Related trials for Vascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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 Vascular Diseases and Stent Complication, run by First Affiliated Hospital of Zhejiang University 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 5 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 27 Sep 2024. 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?
The change of Rutherfor classification (time frame: 24 months). The study lists 3 primary outcomes in all. 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 27 Sep 2024.