Critical IschemiaPhase 3STREAMERNCT02835586
STREAMER : STent Restenosis And MEdicaments Release
A Phase 3 study testing Paclitaxel in people with Critical Ischemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Ischemia
- What is being tested?
- Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Nov 2015
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with critical ischemia of a lower limb with ankle pressure < 50 mmHg
- lesions TASC C and D of the superficial femoral or popliteal artery
Who cannot join
- patient allergic to paclitaxel
- patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy
- patient with contraindication to take 2 anti-aggregants platelets
Trial locations and contacts
1 site in 1 country.
France1 site
department of vascular surgery, Edouard Herriot Hospital, 5 Place d'Arsonval
Lyon, 69003
About this study
Official title: STREAMER : Stent Restenosis and Medicaments Release : Does Local Delivery of Paclitaxel be Safe and Efficient in Stenting of TransAtlantic InterSociety Consensus (TASC) Class C and D Femoropopliteal Artery Lesions
It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia.
- Conditions
- Critical Ischemia
- Being tested
- Paclitaxel
- Keywords
- paclitaxel, critical ischemia, restenosis, femoropopliteal artery lesions TASC C and D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Paclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery and/or popliteal artery after stenting. Dosing will be based on the lesion surface area and will be calculated using the following formula : 22/7 x diameter (mm) x length (mm) x 3 µg/mm3
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel delivery in femoropopliteal artery | Experimental | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with femoropopliteal artery restenosis
defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound
Measured: 12 months
Secondary outcomes (4)
Occurence of adverse events due to paclitaxel
biological adverse events (thrombopenia, neutropenia)
Measured: From1 day to 12 months
Number of patients with target lesion revascularization
number of subjects who need a new revascularization on the same artery (femoropopliteal)
Measured: 12 months
Occurence of amputation free-survival
Measured: 12 months
cumulated rate of morbi-mortality (TCMM)
myocardial infarction, death, vascular ischemic accident, cardiac angina, major amputation, new hospitalization or new surgery for hematoma, thrombosis or false aneurysm
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startMay 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IschemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nellie DELLA SCHIAVA, MD, Principal investigator, department of vascular surgery, Edouard Herriot Hospital, LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835586
- Sponsor's protocol ID
- 2011-701
- Acronym
- STREAMER
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STREAMER : Stent Restenosis and Medicaments Release : Does Local Delivery of Paclitaxel be Safe and Efficient in Stenting of TransAtlantic InterSociety Consensus (TASC) Class C and D Femoropopliteal Artery Lesions
- ClinicalTrials.gov ID
- NCT02835586
- Acronym / sponsor ID
- STREAMER / 2011-701
- Conditions
- Critical Ischemia
- Keywords
- paclitaxel, critical ischemia, restenosis, femoropopliteal artery lesions TASC C and D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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.
It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel delivery in femoropopliteal artery | Experimental | Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with critical ischemia of a lower limb with ankle pressure < 50 mmHg
- lesions TASC C and D of the superficial femoral or popliteal artery
Key exclusion criteria (3 listed)
- patient allergic to paclitaxel
- patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy
- patient with contraindication to take 2 anti-aggregants platelets
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 |
|---|---|---|
| PaclitaxelPaclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery and/or popliteal artery after stenting. Dosing will be based on the lesion surface area and will be calculated using the following formula : 22/7 x diameter (mm) x length (mm) x 3 µg/mm3 | Drug | paclitaxel delivery in femoropopliteal artery |
Primary outcome
Percentage of patients with femoropopliteal artery restenosis
Time frame: 12 months
defined as restenosis > 50 % with a velocity pick > 2,5 on duplex ultrasound
4 secondary outcomes
Occurence of adverse events due to paclitaxel
Time frame: From1 day to 12 months
Number of patients with target lesion revascularization
Time frame: 12 months
Occurence of amputation free-survival
Time frame: 12 months
cumulated rate of morbi-mortality (TCMM)
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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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.
Nellie DELLA SCHIAVA, MD principal investigator
department of vascular surgery, Edouard Herriot Hospital, LYON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel in people with Critical Ischemia, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jul 2016. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with femoropopliteal artery restenosis (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 18 Jul 2016.