Peripheral Artery DiseaseNCT03521843
LDD in Treatment of Femoropopliteal ISR
A study testing balloon dilation only and balloon dilation+local drug delivery in people with Peripheral Artery Disease and In-stent Restenosis, run by RenJi Hospital at 1 site in China.
Trial summary
This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Artery Disease, In-stent Restenosis
- What is being tested?
- balloon dilation only and balloon dilation+local drug delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Oct 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
- have signed the informed consent
- age of 18-80 years old
- femoropopliteal artery disease (Rutherford 2-4)
- femoropopliteal in-stent restenosis (≥70%)
- length of lesion ≤ 20cm
- at least one infrapopliteal run-off vessel
Who cannot join
- serum Cr > 150 umol/L
- patients with acute thrombosis
- stent fracture within femoropopliteal artery
- allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
- already recruited into other clinical trials that could influence the outcome of this study
- pregnancy and lactation
- relatively easy bleeding
- malignancy or irreversible organ failure
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Meng Ye, M.D., Ph.D., +86 13817145123, 13817145123@163.com
About this study
Official title: Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis
This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 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 after stent implantation. The chronic inflammation induced by stenting could be a main reason of restenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices are developed. Here, the investigators propose the hypothesis that using local drug delivery with TAPAS balloon system can relieve the inflammation induced by the stent implantation and balloon dilation. Therefore, 40 patients of femoropopliteal in-stent restenosis will be randomly allocated into the group "balloon dilation+local drug delivery with balloon system" or "balloon dilation only". The 1-year patency rate,12-month late lumen loss, incidence of complications, imaging parameters will be compared between two groups.
- Conditions
- Peripheral Artery Disease, In-stent Restenosis
- Being tested
- balloon dilation only, balloon dilation+local drug delivery
- Keywords
- femoropopliteal occlusive disease, 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.
balloon dilation onlyDevice
The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
balloon dilation+local drug deliveryDevice
The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
| Study group | Role | What they receive |
|---|---|---|
| balloon dilation only | Experimental | The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis. Receives: Device: balloon dilation only |
| balloon dilation+local drug delivery | Experimental | The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis. Receives: Device: balloon dilation+local drug delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion revascularization
the revascularization rate of target lesion
Measured: 12 months
Secondary outcomes (9)
MLD
minimal lumen diameter of target vessel at 6 months
Measured: 6 months
restenosis rate
the rate of re-stenosis (≥50) of target vessel at 6 months
Measured: 6 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
12-month patency rate
the 12-month patency rate of target vessel
Measured: 12 months
6-month patency rate
the 6-month patency rate of target vessel
Measured: 6 months
late lumen loss rate at secondary intervention
the rate of late lumen loss of target vessel at secondary intervention within 12 months
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 posted11 May 2018
- Study start1 Jan 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion31 Oct 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521843
- Sponsor's protocol ID
- 12345678
- Status last verified
- Apr 2018
- First submitted
- 30 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis
- ClinicalTrials.gov ID
- NCT03521843
- Acronym / sponsor ID
- 12345678
- Conditions
- Peripheral Artery Disease, In-stent Restenosis
- Keywords
- femoropopliteal occlusive disease, 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 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 11 May 2018 (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 local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 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 after stent implantation. The chronic inflammation induced by stenting could be a main reason of restenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices are developed. Here, the investigators propose the hypothesis that using local drug delivery with TAPAS balloon system can relieve the inflammation induced by the stent implantation and balloon dilation. Therefore, 40 patients of femoropopliteal in-stent restenosis will be randomly allocated into the group "balloon dilation+local drug delivery with balloon system" or "balloon dilation only". The 1-year patency rate,12-month late lumen loss, incidence of complications, imaging parameters will be compared between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balloon dilation only | Experimental | Device: balloon dilation onlyThe balloon dilation only will be used to treat the femoropopliteal in-stent restenosis. |
| balloon dilation+local drug delivery | Experimental | Device: balloon dilation+local drug deliveryThe balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have signed the informed consent
- age of 18-80 years old
- femoropopliteal artery disease (Rutherford 2-4)
- femoropopliteal in-stent restenosis (≥70%)
- length of lesion ≤ 20cm
Key exclusion criteria (8 listed)
- serum Cr > 150 umol/L
- patients with acute thrombosis
- stent fracture within femoropopliteal artery
- allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
- already recruited into other clinical trials that could influence the outcome of this study
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 |
|---|---|---|
| balloon dilation onlyThe balloon dilation only will be used to treat the femoropopliteal in-stent restenosis. | Device | balloon dilation only |
| balloon dilation+local drug deliveryThe balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis. | Device | balloon dilation+local drug delivery |
Primary outcome
target lesion revascularization
Time frame: 12 months
the revascularization rate of target lesion
9 secondary outcomes
MLD
Time frame: 6 months
restenosis rate
Time frame: 6 months
adverse events
Time frame: 12 months
Rutherford level
Time frame: 12 months
ABI
Time frame: 12 months
main amputation
Time frame: 12 months
12-month patency rate
Time frame: 12 months
6-month patency rate
Time frame: 6 months
late lumen loss rate at secondary intervention
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 11 May 2018.
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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?
A study testing balloon dilation only and balloon dilation+local drug delivery in people with Peripheral Artery Disease and In-stent Restenosis, run by RenJi Hospital 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 6 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 11 May 2018. 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?
Contact Meng Ye, M.D., Ph.D. (+86 13817145123, 13817145123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion revascularization (time frame: 12 months). 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 11 May 2018.