Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— IBREED  

Official title:

Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05189522
• Other study ID #: IBREED
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: May 25, 2024

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: Yann GOUEFFIC, MD
• Phone: 144126172
• Email: ygoueffic[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 25, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Innova Breeze®-based roadmap
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

Other:
• Control Group
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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View Citation

Amighi 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. — View Citation

Andreucci 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. — View Citation

Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849. Erratum In: Circ Res. 2015 Jun 19;117(1):e12. — View Citation

Criqui 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. Erratum In: Circulation. 2021 Aug 31;144(9):e193. — View Citation

Fowkes 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. — View Citation

O'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. — View Citation

Ungprasert 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of iodinated contrast volume	This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.	Day 1
Secondary	Patient safety in terms of radiation exposure at the end of the procedure	This outcome corresponds to the number of DSA runs.	Day 1
Secondary	Staff safety in terms of radiation exposure at the end of the procedure	This outcome corresponds to the Operator exposure (Sv).	Day 1
Secondary	Patient clinical improvement	This outcome corresponds to the clinical status (Rutherford stage).	Month 1
Secondary	Estimation of renal function post-operative	This outcome corresponds to the Glomerular filtration rate (GFR).	Day 4
Secondary	Estimation of renal function at 1 month	This outcome corresponds to the Glomerular filtration rate (GFR)	Month 1