Peripheral Vascular DiseasesRemoveNCT04986098
Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons
An observational study of Peripheral Vascular Diseases, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- TurboHawk and Paclitaxel
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Dec 2023
- How long will I take part?
- 2 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASO patients with femoral popliteal artery occlusion
Who may be able to join
- Age over 18 years old
- Ruthford grade 2-5 patients
- For patients whose arteries in both lower extremities meet the enrollment criteria, both lower extremities can be included
- At least one outflow tract over 10 cm at the distal end of the knee is continuous with a healthy back of the foot or internal and external arteries of the plantar
- The guide wire clearly passed through the lesion and the follow-up treatment was performed. In the case of failed anterograde passage, reverse puncture to achieve the guide wire through the lesion can also be included in the group
- After the failure of the first intracavitary treatment, the blood vessel can be recanalized by the intracavitary treatment again, and it can still be included in the group
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- Patients with aortic iliac artery disease can be included in the group after the aortic artery is opened
- Patients who are willing to participate in this study and sign informed consent
- For severely infected R6 patients, if the infection is effectively controlled, they can be considered for inclusion
Who cannot join
- Patients who refuse to participate in this observational study
- Femoral popliteal artery disease with acute and subacute thrombosis
- Patients with thromboangiitis
- Patients who have failed endovascular treatment and transferred to surgical treatment
- For patients who have received plaque exfoliation on the femoral artery
- Patients who are allergic to heparin, low molecular weight heparin and contrast agents
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- Patients enrolled in other clinical studies in the past 3 months
- Pregnant women
- Patients who have a life span of less than 2 years due to serious diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Sang Hongfei, Doctorate, 18606208970 ext. 0512-67784869, sanghongfei@163.com
About this study
Official title: Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons in the Treatment of Femoral Popliteal Artery Occlusion
DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. The combined application of DA and DCB in the treatment of peripheral arterial disease has a good early and mid-term effect. Konstantinos et al. reported that DARRT has a higher first-phase patency rate compared with DCB. A retrospective study by Sebastian et al. showed that compared with PTA after DA, the combination of DA and DCB has a better event-free survival rate after 12 months of follow-up. Therefore, DA combined with DCB therapy may be one of the best and most promising methods for the treatment of lower extremity ASO.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- TurboHawk, Paclitaxel
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TurboHawkDevice
Directly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel
PaclitaxelDrug
Paclitaxel
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary vascular patency rate
Free-Target lesion reconstruction rate（F-TLR）at 24 months after operation
Measured: 24 months
Major adverse event
MAE within 24 months after surgery
Measured: 24 months
Secondary outcomes (5)
Quality of life assessment
Quality of life assessment (VAS-QOL) after discharge, 1, 3, 6, 12, and 24 months after operation
Measured: 24 months
ABI
Ankle-brachial index (ABI) at discharge, 1, 3, 6, 12, and 24 months after operation
Measured: 24 months
Rutherford classification
Discharge, 1, 3, 6, 12, and 24 months after the Rutherford classification
Measured: 24 months
TLR
The incidence of TLR after discharge, 1, 3, 6, 12, and 24 months
Measured: 24 months
TVR
The incidence of TVR after discharge, 1, 3, 6, 12, and 24 months
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 posted2 Aug 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- 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
- 240 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986098
- Sponsor's protocol ID
- Hongfei Sang
- Acronym
- Remove
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effectiveness and Safety Evaluation of Directional Atherectomy Combined With Drug-coated Balloons in the Treatment of Femoral Popliteal Artery Occlusion
- ClinicalTrials.gov ID
- NCT04986098
- Acronym / sponsor ID
- Remove / Hongfei Sang
- Conditions
- Peripheral Vascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Aug 2021 (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.
DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. The combined application of DA and DCB in the treatment of peripheral arterial disease has a good early and mid-term effect. Konstantinos et al. reported that DARRT has a higher first-phase patency rate compared with DCB. A retrospective study by Sebastian et al. showed that compared with PTA after DA, the combination of DA and DCB has a better event-free survival rate after 12 months of follow-up. Therefore, DA combined with DCB therapy may be one of the best and most promising methods for the treatment of lower extremity ASO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASO patients with femoral popliteal artery occlusion
Key inclusion criteria (9 listed)
- Age over 18 years old
- Ruthford grade 2-5 patients
- For patients whose arteries in both lower extremities meet the enrollment criteria, both lower extremities can be included
- At least one outflow tract over 10 cm at the distal end of the knee is continuous with a healthy back of the foot or internal and external arteries of the plantar
- The guide wire clearly passed through the lesion and the follow-up treatment was performed. In the case of failed anterograde passage, reverse puncture to achieve the guide wire through the lesion can also be included in the group
Key exclusion criteria (9 listed)
- Patients who refuse to participate in this observational study
- Femoral popliteal artery disease with acute and subacute thrombosis
- Patients with thromboangiitis
- Patients who have failed endovascular treatment and transferred to surgical treatment
- For patients who have received plaque exfoliation on the femoral artery
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 |
|---|---|---|
| TurboHawkDirectly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel | Device | – |
| PaclitaxelPaclitaxel | Drug | – |
Primary outcome
Primary vascular patency rate
Time frame: 24 months
Free-Target lesion reconstruction rate（F-TLR）at 24 months after operation
Major adverse event
Time frame: 24 months
MAE within 24 months after surgery
5 secondary outcomes
Quality of life assessment
Time frame: 24 months
ABI
Time frame: 24 months
Rutherford classification
Time frame: 24 months
TLR
Time frame: 24 months
TVR
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 2 Aug 2021.
- 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 Vascular Diseases, run by Second Affiliated Hospital of Soochow 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 9 inclusion and 9 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 2021. 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 vascular patency rate (time frame: 24 months). The study lists 2 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 2 Aug 2021.