Peripheral Artery DiseaseNCT03380650
Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease
A study testing directional atherectomy and locol drug delivery and drug-coated balloon dilation in people with Peripheral Artery Disease and Endovascular Treatment, run by RenJi Hospital.
Trial summary
This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Artery Disease, Endovascular Treatment
- What is being tested?
- directional atherectomy and locol drug delivery and drug-coated balloon dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 30 Dec 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 18-80 years old
- patients of femoropopliteal occlusive disease (Rutherford 2-4)
- length of lesion ≤ 20cm
- have signed the informed consent
Who cannot join
- serum Cr > 150 umol/L
- patients with acute thrombosis
- received endovascular treatment for femoropopliteal disease in recent 6 months
- less than 1 run-off vessel
- allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
- pregnancy and lactation
- relatively easy bleeding
- malignancy or irreversible organ failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease
This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients of femoropopliteal occlusive disease will randomly receive directional atherectomy plus local drug delivery using balloon catheter system and dilation using drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year patency rate of target vessel) in 1 year after the treatment will be compared.
Read the detailed description
Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency rate after stent implantation. The chronic inflammation induced by stenting could be a main reason of re-stenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices, such as paclitaxel-coated balloon dilation, directional atherectomy, are developed. Directional atherectomy can effectively remove the atherosclerosis plaque but leave the inflammatory reaction along the atherectomy route. Here, we propose the hypothesis that using local drug delivery with balloon system can relieve the inflammation induced by atherectomy. Therefore, 40 patients of femoropopliteal occlusive disease will be randomly allocated into the group "directional atherectomy+local drug delivery with balloon system" or "drug-coated balloon only". The 1-year patency rate, incidence of complications, imaging parameters will be compared between groups.
- Conditions
- Peripheral Artery Disease, Endovascular Treatment
- Being tested
- directional atherectomy and locol drug delivery, drug-coated balloon dilation
- Keywords
- femoropopliteal occlusive disease, directional atherectomy, local drug delivery, endovascular treatment
- 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.
directional atherectomy and locol drug deliveryDevice
combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease
drug-coated balloon dilationDevice
use of drug-coated balloon dilation for the treatment of femoralpopliteal disease
| Study group | Role | What they receive |
|---|---|---|
| durg-coated balloon dilation | Other | The drug-coated balloon will be used to treat the femoropopliteal occlusion. Receives: Device: drug-coated balloon dilation |
| directional atherectomy and LDD | Other | The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion. Receives: Device: directional atherectomy and locol drug delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss rate
the rate of late lumen loss of target vessel
Measured: 12 months
patency rate
the rate of patency of target vessel
Measured: 6 months
patency rate
the rate of patency of target vessel
Measured: 12 months
Secondary outcomes (8)
MLD
minimal lumen diameter of target vessel at 6 months
Measured: 12 months
clinical outcomes
rate of re-intervention of target vessel
Measured: 12 months
incidence of complications
incidence of treatment induced major complications
Measured: 12 months
re-stenosis rate
the rate of re-stenosis (≥50)
Measured: 12 months
adverse events
incidence of treatment related adverse events
Measured: 12 months
Rutherford level
change of Rutherford level
Measured: 12 months
ABI
change of ankle brachial index
Measured: 12 months
main amputation
rate of main amputation
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 posted21 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Zhang, M.D., Ph.D., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380650
- Sponsor's protocol ID
- 2017-092
- Status last verified
- Dec 2017
- First submitted
- 13 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease
- ClinicalTrials.gov ID
- NCT03380650
- Acronym / sponsor ID
- 2017-092
- Conditions
- Peripheral Artery Disease, Endovascular Treatment
- Keywords
- femoropopliteal occlusive disease, directional atherectomy, local drug delivery, endovascular treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 21 Dec 2017 (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 evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients of femoropopliteal occlusive disease will randomly receive directional atherectomy plus local drug delivery using balloon catheter system and dilation using drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year patency rate of target vessel) in 1 year after the treatment will be compared.
Detailed description
Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency rate after stent implantation. The chronic inflammation induced by stenting could be a main reason of re-stenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices, such as paclitaxel-coated balloon dilation, directional atherectomy, are developed. Directional atherectomy can effectively remove the atherosclerosis plaque but leave the inflammatory reaction along the atherectomy route. Here, we propose the hypothesis that using local drug delivery with balloon system can relieve the inflammation induced by atherectomy. Therefore, 40 patients of femoropopliteal occlusive disease will be randomly allocated into the group "directional atherectomy+local drug delivery with balloon system" or "drug-coated balloon only". The 1-year patency rate, incidence of complications, imaging parameters will be compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| durg-coated balloon dilation | Other | Device: drug-coated balloon dilationThe drug-coated balloon will be used to treat the femoropopliteal occlusion. |
| directional atherectomy and LDD | Other | Device: directional atherectomy and locol drug deliveryThe directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age of 18-80 years old
- patients of femoropopliteal occlusive disease (Rutherford 2-4)
- length of lesion ≤ 20cm
- have signed the informed consent
Key exclusion criteria (8 listed)
- serum Cr > 150 umol/L
- patients with acute thrombosis
- received endovascular treatment for femoropopliteal disease in recent 6 months
- less than 1 run-off vessel
- allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
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 |
|---|---|---|
| directional atherectomy and locol drug deliverycombined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease | Device | directional atherectomy and LDD |
| drug-coated balloon dilationuse of drug-coated balloon dilation for the treatment of femoralpopliteal disease | Device | durg-coated balloon dilation |
Primary outcome
late lumen loss rate
Time frame: 12 months
the rate of late lumen loss of target vessel
patency rate
Time frame: 6 months
the rate of patency of target vessel
patency rate
Time frame: 12 months
the rate of patency of target vessel
8 secondary outcomes
MLD
Time frame: 12 months
clinical outcomes
Time frame: 12 months
incidence of complications
Time frame: 12 months
re-stenosis rate
Time frame: 12 months
adverse events
Time frame: 12 months
Rutherford level
Time frame: 12 months
ABI
Time frame: 12 months
main amputation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Lan Zhang, M.D., Ph.D. principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing directional atherectomy and locol drug delivery and drug-coated balloon dilation in people with Peripheral Artery Disease and Endovascular Treatment, run by RenJi Hospital.
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 8 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 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shuofei Yang, M.D., Ph.D. (+86 13764227372, doctor_yangshuofei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late lumen loss rate (time frame: 12 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 21 Dec 2017.