Femoropopliteal Arterial StenosisBalloon-angioNCT03428204
Effect of Inflation on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment
A study testing Balloon dilation during 180 seconds and Balloon dilation during 300 seconds in people with Femoropopliteal Arterial Stenosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with flow limiting dissection or recoil with residual stenosis often require additional procedures such as stent placement or prolonged… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Femoropopliteal Arterial Stenosis
- What is being tested?
- Balloon dilation during 180 seconds and Balloon dilation during 300 seconds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Nov 2017to 1 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic atherosclerotic stenotic lesions of the femoropopliteal artery suitable for angioplasty in the adult population
Who cannot join
- Artery lesions shorter than 1 cm and longer than 10 cm length, total occlusions, severe calcification, previous angioplasty with current restenosis, previous stenting with current insistent restenosis and subintimal recanalization of the lesion
- No pregnant and nursing women will be included.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Parla Astarci, MD, PhD, 0032 2 764 ext. 6107, parla.astarci@uclouvain.be
Maxime Elens, MD, 0032 2 764 ext. 8063, maxime.elens@uclouvain.be
About this study
Official title: Effect of Different Inflation Times on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment: a Prospective Randomized Clinical Trial
Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with flow limiting dissection or recoil with residual stenosis often require additional procedures such as stent placement or prolonged balloon dilation. A shorter balloon inflation time of 30 sec will be accompanied by a higher number of flow limiting dissection or recoil, demanding a time consuming and expensive stent placement or balloon redilatation. The effect of different balloon inflation times has only been assessed ones in peripheral balloon angioplasty with better outcomes after prolonged balloon inflation.
- Conditions
- Femoropopliteal Arterial Stenosis
- Being tested
- Balloon dilation during 180 seconds, Balloon dilation during 300 seconds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon dilation during 180 secondsProcedure or surgery
Also called Balloon dilation of femoropopliteal artery lesions during 180 seconds
Percutaneous angioplasty with balloon dilation during 180 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
Balloon dilation during 300 secondsProcedure or surgery
Also called Balloon dilation of femoropopliteal artery lesions during 300 seconds
Percutaneous angioplasty with balloon dilation during 300 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
| Study group | Role | What they receive |
|---|---|---|
| 180 seconds balloon dilation | Other | Percutaneous angioplasty with balloon dilation during 180 seconds for percutaneous treatment of femoropopliteal artery stenosis Receives: Procedure: Balloon dilation during 180 seconds |
| 300 seconds balloon dilation | Other | Percutaneous angioplasty with balloon dilation during 300 seconds for percutaneous treatment of femoropopliteal artery stenosis Receives: Procedure: Balloon dilation during 300 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of residual stenosis between both groups
The primary outcome of the study is to assess the difference in number of residual stenosis after balloon dilatation of the arterial lesion between both groups (3min and 5min). A residual stenosis (measured on the angiogram) responsible for an arterial stenosis of >30% will be defined as unsuccessful treatment.
The group with the lowest number of arterial restenosis >30% after dilatation has the best primary outcome.
Measured: at 3 or 5 minutes
Secondary outcomes (1)
Number of redilatation or additional stenting between both groups
The secondary outcome of the study is to evaluate the difference in need of redilatation or provisional stenting after the first dilatation between both groups (3 vs 5min). If an arterial stenosis of >30% after dilatation is measured, a redilatation of an additional stenting will be placed. The group with the lowest number of redilatation or additional stenting after dilatation has the best secondary outcome.
Measured: at 3 or 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start28 Nov 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Arterial StenosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Model description
- The effect of two balloon inflation times will be evaluated in peripheral balloon angioplasty
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parla Astarci, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428204
- Sponsor's protocol ID
- 2017/17AOU/406
- Acronym
- Balloon-angio
- Status last verified
- Mar 2019
- First submitted
- 8 Dec 2017
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Inflation Times on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03428204
- Acronym / sponsor ID
- Balloon-angio / 2017/17AOU/406
- Conditions
- Femoropopliteal Arterial Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 9 Feb 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.
Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with flow limiting dissection or recoil with residual stenosis often require additional procedures such as stent placement or prolonged balloon dilation. A shorter balloon inflation time of 30 sec will be accompanied by a higher number of flow limiting dissection or recoil, demanding a time consuming and expensive stent placement or balloon redilatation. The effect of different balloon inflation times has only been assessed ones in peripheral balloon angioplasty with better outcomes after prolonged balloon inflation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The effect of two balloon inflation times will be evaluated in peripheral balloon angioplasty
| Arm | Type | Receives |
|---|---|---|
| 180 seconds balloon dilation | Other | Procedure: Balloon dilation during 180 secondsPercutaneous angioplasty with balloon dilation during 180 seconds for percutaneous treatment of femoropopliteal artery stenosis |
| 300 seconds balloon dilation | Other | Procedure: Balloon dilation during 300 secondsPercutaneous angioplasty with balloon dilation during 300 seconds for percutaneous treatment of femoropopliteal artery stenosis |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic atherosclerotic stenotic lesions of the femoropopliteal artery suitable for angioplasty in the adult population
Key exclusion criteria (2 listed)
- Artery lesions shorter than 1 cm and longer than 10 cm length, total occlusions, severe calcification, previous angioplasty with current restenosis, previous stenting with current insistent restenosis and subintimal recanalization of the lesion
- No pregnant and nursing women will be included.
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 during 180 secondsAlso: Balloon dilation of femoropopliteal artery lesions during 180 secondsPercutaneous angioplasty with balloon dilation during 180 seconds as a method for percutaneous treatment of femoropopliteal artery lesions | Procedure or surgery | 180 seconds balloon dilation |
| Balloon dilation during 300 secondsAlso: Balloon dilation of femoropopliteal artery lesions during 300 secondsPercutaneous angioplasty with balloon dilation during 300 seconds as a method for percutaneous treatment of femoropopliteal artery lesions | Procedure or surgery | 300 seconds balloon dilation |
Primary outcome
Number of residual stenosis between both groups
Time frame: at 3 or 5 minutes
The primary outcome of the study is to assess the difference in number of residual stenosis after balloon dilatation of the arterial lesion between both groups (3min and 5min). A residual stenosis (measured on the angiogram) responsible for an arterial stenosis of >30% will be defined as unsuccessful treatment. The group with the lowest number of arterial restenosis >30% after dilatation has the best primary outcome.
1 secondary outcome
Number of redilatation or additional stenting between both groups
Time frame: at 3 or 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Related trials for Femoropopliteal Arterial Stenosis
Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Not yet recruitingPhase 2/3
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery Disease
Enrolling by invitationObservational study
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
Femoral Artery Stenosis, Angioplasty
Recruiting
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
Peripheral Arterial Disease, Vascular Diseases
Not yet recruitingObservational study
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
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.
Parla Astarci, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 during 180 seconds and Balloon dilation during 300 seconds in people with Femoropopliteal Arterial Stenosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 2 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 Mar 2019. 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 Belgium. 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 Parla Astarci, MD, PhD (0032 2 764 ext. 6107, parla.astarci@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of residual stenosis between both groups (time frame: at 3 or 5 minutes). 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 Mar 2019.