Peripheral Arterial DiseaseIBREEDNCT05189522
Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
A study testing Innova Breeze®-based roadmap in people with Peripheral Arterial Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Over the past decade, interventional endovascular treatment, whenever feasible, has become the first line management in the treatment of lower extremity arterial disease (LEAD) for many indications. Growth of endovascular therapy was based on shorter hospital length of stay and lower complications rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Innova Breeze®-based roadmap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to 25 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years
- Patient has a history of symptomatic peripheral arterial disease (Rutherford classification 2-6)
- Patients with indication of femoropopliteal revascularization according the European guidelines (1)
- Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
- French-speaking patient
- Patient is affiliated to the Social Security or equivalent system
- Patients is able and willing to give free, informed and express oral consent
- Iliac and/or below the knee lesions are allowed in combination to femoropopliteal lesions
Who cannot join
- Upper limb approach
- Femoral antegrade approach
- Pregnant or breastfeeding woman
- Adult under guardianship or trusteeship
- Iodinated contrast allergy
- Reduction in estimated Glomerular Filtration Ratio (eGFR) ≤ 29 ml/min/m2 (11)
Show all 10Show fewer
- Patients included in other studies which interact with intraoperative imaging protocols
- Concurrent participation in an interventional (drug or device) study for which the follow-up period is not complete.
- Patient under tutorship or curatorship
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Yann GOUEFFIC, MD, 144126172 ext. +33, ygoueffic@ghpsj.fr
About this study
Over the past decade, interventional endovascular treatment, whenever feasible, has become the first line management in the treatment of lower extremity arterial disease (LEAD) for many indications. Growth of endovascular therapy was based on shorter hospital length of stay and lower complications rates. This minimally invasive procedure allows the revascularization of the lower limbs under fluoroscopy guidance, with injection of iodinated contrast allowing to analyze the arteries. However, many of these patients present renal insufficiency which could be worsened due to the iodinated contrast injections during the endovascular procedure for LEAD. Consequently, the vascular interventionalist should find a way to achieve patient revascularization while minimizing iodinated contrast injections in order to maintain the renal function.
The aim of this study is to compare the amount of iodine contrast used during LEAD endovascular revascularization with and without the Innova Breeze® and blended roadmap software.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Innova Breeze®-based roadmap, Control Group
- 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.
Innova Breeze®-based roadmapDevice
An Innova Breeze® bolus chase acquisition is realized to assess the final result of the Revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm
Control GroupOther
2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence.
After treatment overall limb assessment will be done through multiple staged DSA.
Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device.
DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used.
For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Innova Breeze®-based roadmap | Experimental | An Innova Breeze® bolus chase acquisition is realized prior to the revascularization to assess the lesions of the entire target limb. Guidance to the different lesions is done using a 2D roadmap based on the Innova Breeze® bolus acquisition frames if the patient position has not moved on the table.
An Innova Breeze® bolus chase acquisition is realized to assess the final result of the revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device.
DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. Innova Breeze® bolus chase acquisitions are performed with the injector set at 4mL/s and the volume at 24mL (pressure limit 1000psi). An injector with iodinated contrast (50% of dilution) will be used. Receives: Device: Innova Breeze®-based roadmap |
| control group | Other | 2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence.
After treatment overall limb assessment will be done through multiple staged DSA.
Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device.
DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used.
For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of iodinated contrast volume
This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.
Measured: Day 1
Secondary outcomes (5)
Patient safety in terms of radiation exposure at the end of the procedure
This outcome corresponds to the number of DSA runs.
Measured: Day 1
Staff safety in terms of radiation exposure at the end of the procedure
This outcome corresponds to the Operator exposure (Sv).
Measured: Day 1
Patient clinical improvement
This outcome corresponds to the clinical status (Rutherford stage).
Measured: Month 1
Estimation of renal function post-operative
This outcome corresponds to the Glomerular filtration rate (GFR).
Measured: Day 4
Estimation of renal function at 1 month
This outcome corresponds to the Glomerular filtration rate (GFR)
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start26 Jan 2022
- Primary completion10 Feb 2024 (estimated)
- Study completion25 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann GOUEFFIC, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189522
- Sponsor's protocol ID
- IBREED
- Acronym
- IBREED
- Status last verified
- Mar 2023
- First submitted
- 29 Dec 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
PubMed 28886620Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
PubMed 23915883Criqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW, McDermott MM, Misra S, Ujueta F; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. 2021 Aug 31;144(9):e171-e191. doi: 10.1161/CIR.0000000000001005. Epub 2021 Jul 28.
PubMed 34315230Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
PubMed 25908725O'Hare AM, Glidden DV, Fox CS, Hsu CY. High prevalence of peripheral arterial disease in persons with renal insufficiency: results from the National Health and Nutrition Examination Survey 1999-2000. Circulation. 2004 Jan 27;109(3):320-3. doi: 10.1161/01.CIR.0000114519.75433.DD. Epub 2004 Jan 19.
PubMed 14732743Ungprasert P, Pornratanarangsi S. Correlation between peripheral arterial disease and stage of chronic kidney disease. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S46-50.
PubMed 21728271Amighi J, Schlager O, Haumer M, Dick P, Mlekusch W, Loewe C, Bohmig G, Koppensteiner R, Minar E, Schillinger M. Renal artery stenosis predicts adverse cardiovascular and renal outcome in patients with peripheral artery disease. Eur J Clin Invest. 2009 Sep;39(9):784-92. doi: 10.1111/j.1365-2362.2009.02180.x. Epub 2009 Jun 12.
PubMed 19522837Andreucci M, Faga T, Serra R, De Sarro G, Michael A. Update on the renal toxicity of iodinated contrast drugs used in clinical medicine. Drug Healthc Patient Saf. 2017 May 22;9:25-37. doi: 10.2147/DHPS.S122207. eCollection 2017.
PubMed 28579836
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT05189522
- Acronym / sponsor ID
- IBREED / IBREED
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 25 May 2024 (estimated)
- First posted
- 12 Jan 2022 (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.
Over the past decade, interventional endovascular treatment, whenever feasible, has become the first line management in the treatment of lower extremity arterial disease (LEAD) for many indications. Growth of endovascular therapy was based on shorter hospital length of stay and lower complications rates. This minimally invasive procedure allows the revascularization of the lower limbs under fluoroscopy guidance, with injection of iodinated contrast allowing to analyze the arteries. However, many of these patients present renal insufficiency which could be worsened due to the iodinated contrast injections during the endovascular procedure for LEAD. Consequently, the vascular interventionalist should find a way to achieve patient revascularization while minimizing iodinated contrast injections in order to maintain the renal function.
The aim of this study is to compare the amount of iodine contrast used during LEAD endovascular revascularization with and without the Innova Breeze® and blended roadmap software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Innova Breeze®-based roadmap | Experimental | Device: Innova Breeze®-based roadmapAn Innova Breeze® bolus chase acquisition is realized prior to the revascularization to assess the lesions of the entire target limb. Guidance to the different lesions is done using a 2D roadmap based on the Innova Breeze® bolus acquisition frames if the patient position has not moved on the table. An Innova Breeze® bolus chase acquisition is realized to assess the final result of the revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. Innova Breeze® bolus chase acquisitions are performed with the injector set at 4mL/s and the volume at 24mL (pressure limit 1000psi). An injector with iodinated contrast (50% of dilution) will be used. |
| control group | Other | Other: Control Group2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence. After treatment overall limb assessment will be done through multiple staged DSA. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used. For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient ≥ 18 years
- Patient has a history of symptomatic peripheral arterial disease (Rutherford classification 2-6)
- Patients with indication of femoropopliteal revascularization according the European guidelines (1)
- Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
- French-speaking patient
Key exclusion criteria (10 listed)
- Upper limb approach
- Femoral antegrade approach
- Pregnant or breastfeeding woman
- Adult under guardianship or trusteeship
- Iodinated contrast allergy
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 |
|---|---|---|
| Innova Breeze®-based roadmapAn Innova Breeze® bolus chase acquisition is realized to assess the final result of the Revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm | Device | Innova Breeze®-based roadmap |
| Control Group2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence. After treatment overall limb assessment will be done through multiple staged DSA. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used. For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory. | Other | control group |
Primary outcome
Amount of iodinated contrast volume
Time frame: Day 1
This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.
5 secondary outcomes
Patient safety in terms of radiation exposure at the end of the procedure
Time frame: Day 1
Staff safety in terms of radiation exposure at the end of the procedure
Time frame: Day 1
Patient clinical improvement
Time frame: Month 1
Estimation of renal function post-operative
Time frame: Day 4
Estimation of renal function at 1 month
Time frame: Month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 28886620Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
- Background: PubMed 23915883Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
- Background: PubMed 34315230Criqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW, McDermott MM, Misra S, Ujueta F; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. 2021 Aug 31;144(9):e171-e191. doi: 10.1161/CIR.0000000000001005. Epub 2021 Jul 28.
- Background: PubMed 25908725Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
- Background: PubMed 14732743O'Hare AM, Glidden DV, Fox CS, Hsu CY. High prevalence of peripheral arterial disease in persons with renal insufficiency: results from the National Health and Nutrition Examination Survey 1999-2000. Circulation. 2004 Jan 27;109(3):320-3. doi: 10.1161/01.CIR.0000114519.75433.DD. Epub 2004 Jan 19.
- Background: PubMed 21728271Ungprasert P, Pornratanarangsi S. Correlation between peripheral arterial disease and stage of chronic kidney disease. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S46-50.
- Background: PubMed 19522837Amighi J, Schlager O, Haumer M, Dick P, Mlekusch W, Loewe C, Bohmig G, Koppensteiner R, Minar E, Schillinger M. Renal artery stenosis predicts adverse cardiovascular and renal outcome in patients with peripheral artery disease. Eur J Clin Invest. 2009 Sep;39(9):784-92. doi: 10.1111/j.1365-2362.2009.02180.x. Epub 2009 Jun 12.
- Background: PubMed 28579836Andreucci M, Faga T, Serra R, De Sarro G, Michael A. Update on the renal toxicity of iodinated contrast drugs used in clinical medicine. Drug Healthc Patient Saf. 2017 May 22;9:25-37. doi: 10.2147/DHPS.S122207. eCollection 2017.
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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.
Yann GOUEFFIC, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innova Breeze®-based roadmap in people with Peripheral Arterial Disease, run by Fondation Hôpital Saint-Joseph 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 8 inclusion and 10 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 7 Mar 2023. 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.
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 Yann GOUEFFIC, MD (144126172 ext. +33, ygoueffic@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of iodinated contrast volume (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189522, which also lists 8 linked publications.
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 7 Mar 2023.