Safety and Efficacy Evaluation of Orbital Atherectomy System in de Novo Calcified Lesions

Angiography Clinical Trial

— REFORCE  

Official title:

French Registry to Evaluate the Safety and Efficacy of the Diamondback 360TM Orbital Atherectomy System in the Preparation of Calcified Coronary Lesions Before Implantation of a Coronary Endoprothesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417022
• Other study ID #: 2021-A02662-39
• Status: Recruiting
• Start date: June 15, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Centre Recherche Cardio Vasculaire Alpes
• Contact: Jacques Monségu
• Phone: +33621273352
• Email: jacquesmonsegu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a French, prospective, single-arm, multi-center registry to confirm the safety and efficacy of the Diamondback 360 TM Orbital Atherectomy System in the preparation of de novo calcified coronary lesions before implantation of a coronary endoprothesis in adult subjects. The primary safety endpoint is 30-day MACE and the efficacy endpoint is procedural success.

Description:

Treatment of calcified lesions, caused in 6 to 20% of patients, remains a challenge. Presence of coronary calcifications complicates stent placement resulting in up to 50% malapposition or under-expansion of the stent and is associated with a higher frequency of major adverse cardiac events (MACE). In order to reduce these risks, preparation of these lesions before the implantation of a coronary stent is essential. The arrival on the European market of a new Orbital atherectomy system leads to consider its use in the preparation of such lesions. The orbital atherectomy system uses a diamond-coated eccentric crown that abrades calcified plaque and develops pulsatile forces on the wall. It reduces calcified plaque and modifies plaque with fractures, facilitating stent placement and allowing for optimal stent expansion. ORBIT I and ORBIT II clinical trials were conducted in the United States to evaluate the safety of using the Orbital Atherectomy System in de novo calcified coronary lesions in adults. These 2 trials demonstrated that orbital atherectomy not only facilitated stenting, but also improved clinical outcomes compared to historical outcomes. The recent obtaining of CE marking allows the use of this very promising medical device in France.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects = 18 years
• Patients with a clinical indication for coronary angioplasty and presenting a de novo calcified lesion
• The target vessel reference diameter must be >= 2.5mm and <= 4.0 mm.
• Lesion length <= 40 mm
• The target vessel must be a coronary artery with a stenosis of >70%
• Patients able to understand and provide informed consent
• Patients with Social Security coverage

Exclusion Criteria:

• Patients with an LVEF < 25%.
• Patient with hypersensitivity to egg, soy or peanut proteins or to one of the active substances or one of the excipients of ViperSlide lubricant.
• Pregnant or breastfeeding woman
• Unwilling or unable to sign the Informed Consent
• Patients under judicial protection, tutorship or curatorship
• Angiographic criteria: Intra-stent stenosis, Presence of a chronic total occlusion (CTO), Bypass lesion, Target vessel excessively tortuous, Presence of a thrombus, Presence of a single permeable vessel

Related Conditions & MeSH terms

• Angiography
• Calcinosis
• Coronary Calcification

Intervention

Device:
• Diamondback 360TM orbital atherectomy system
Use of the Diamondback 360TM orbital atherectomy system in the preparation of calcified coronary lesions before implantation of a coronary endoprothesis

Locations

Country	Name	City	State
France	GCS-ES Axium-Rambot	Aix-en-Provence
France	Centre Hospitalier Antibes - Juan-Les-Pins	Antibes
France	Hôpital Européen de la Roseraie	Aubervilliers
France	Centre Hospitalier d'Avignon	Avignon
France	Clinique Rhône Durance	Avignon
France	Centre Hospitalier Universitaire de Clermont-Ferrand	Clermont-Ferrand
France	Pôle Santé République - ELSAN	Clermont-Ferrand
France	Groupe Hospitalier Mutualiste de Grenoble	Grenoble
France	Centre Hospitalier de Haguenau	Haguenau
France	Centre Hospitalier Marne la Vallée	Jossigny
France	Hôpital de la Timone	Marseille
France	Hôpital Privé du Confluent	Nantes
France	Centre Hospitalier Universitaire de Nîmes	Nîmes
France	Clinique Saint Hilaire	Rouen
France	Institut Arnault Tzanck	Saint-Laurent-du-Var
France	CHU Strasbourg	Strasbourg
France	Centre Hospitalier Intercommunal Toulon - La Seyne/Mer	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Recherche Cardio Vasculaire Alpes

Country where clinical trial is conducted

France, 

References & Publications (13)

Benezet J, Diaz de la Llera LS, Cubero JM, Villa M, Fernandez-Quero M, Sanchez-Gonzalez A. Drug-eluting stents following rotational atherectomy for heavily calcified coronary lesions: long-term clinical outcomes. J Invasive Cardiol. 2011 Jan;23(1):28-32. — View Citation

Bhatt P, Parikh P, Patel A, Chag M, Chandarana A, Parikh R, Parikh K. Orbital atherectomy system in treating calcified coronary lesions: 3-Year follow-up in first human use study (ORBIT I trial). Cardiovasc Revasc Med. 2014 Jun;15(4):204-8. doi: 10.1016/j.carrev.2014.03.004. Epub 2014 Mar 19. — View Citation

Bouisset F, Barbato E, Reczuch K, Dobrzycki S, Meyer-Gessner M, Bressollette E, Cayla G, Lhermusier T, Zajdel W, Palazuelos Molinero J, Ferenc M, Ribichini FL, Carrie D. Clinical outcomes of PCI with rotational atherectomy: the European multicentre Euro4C registry. EuroIntervention. 2020 Jul 17;16(4):e305-e312. doi: 10.4244/EIJ-D-19-01129. — View Citation

Chambers JW, Feldman RL, Himmelstein SI, Bhatheja R, Villa AE, Strickman NE, Shlofmitz RA, Dulas DD, Arab D, Khanna PK, Lee AC, Ghali MG, Shah RR, Davis TP, Kim CY, Tai Z, Patel KC, Puma JA, Makam P, Bertolet BD, Nseir GY. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC Cardiovasc Interv. 2014 May;7(5):510-8. doi: 10.1016/j.jcin.2014.01.158. — View Citation

Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992 Jul;86(1):64-70. doi: 10.1161/01.cir.86.1.64. — View Citation

Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19. — View Citation

Kobayashi Y, Okura H, Kume T, Yamada R, Kobayashi Y, Fukuhara K, Koyama T, Nezuo S, Neishi Y, Hayashida A, Kawamoto T, Yoshida K. Impact of target lesion coronary calcification on stent expansion. Circ J. 2014;78(9):2209-14. doi: 10.1253/circj.cj-14-0108. Epub 2014 Jul 14. — View Citation

Lee M, Genereux P, Shlofmitz R, Phillipson D, Anose BM, Martinsen BJ, Himmelstein SI, Chambers JW. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017 Jun;18(4):261-264. doi: 10.1016/j.carrev.2017.01.011. Epub 2017 Jan 23. — View Citation

Mosseri M, Satler LF, Pichard AD, Waksman R. Impact of vessel calcification on outcomes after coronary stenting. Cardiovasc Revasc Med. 2005 Oct-Dec;6(4):147-53. doi: 10.1016/j.carrev.2005.08.008. — View Citation

Moussa I, Di Mario C, Moses J, Reimers B, Di Francesco L, Martini G, Tobis J, Colombo A. Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. Circulation. 1997 Jul 1;96(1):128-36. doi: 10.1161/01.cir.96.1.128. — View Citation

Onuma Y, Tanimoto S, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Dorange C, Miquel-Hebert K, Veldhof S, Serruys PW. Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):634-42. doi: 10.1002/ccd.22541. — View Citation

Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5. — View Citation

Sturm R, Martinsen BJ, Valle JA, Waldo SW, Behrens AN, Armstrong EJ. Orbital Atherectomy for Treatment of Complex Severely Calcified Coronary Artery Lesions: Insights from a Veterans Affairs Cohort. Cardiovasc Revasc Med. 2020 Mar;21(3):330-333. doi: 10.1016/j.carrev.2019.06.013. Epub 2019 Jun 28. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint : Major Adverse Cardiac Event (MACE)	The Diamondback 360°® Orbital Atherectomy System safety was evaluated by a composite of MACE at 30-days post procedure. MACE is composed of : Myocardial infarction : Type I and/or Type IV; TVR - defined as revascularization at the target vessel after the completion of the index procedure.; Cardiac death.	30 days
Secondary	Efficacy Endpoint : Revascularization success rate	Revascularization success was defined as successful stent placement with < 30% residual stenosis and without severe angiographic complications during intervention and/or MACE during the period of the patient's hospitalization.; Severe angiographic complications were defined as severe dissection (Type C to F) , perforation and persistent slow flow or no flow, Atrioventricular conduction disorder.	Until hospital discharge after index procedure, average estimated at 48 hours
Secondary	Safety Endpoint : 12 Month MACE	See MACE definition in the primary outcome.	12 months
Secondary	Safety endpoint : Comparison of MACE with rotational atherectomy	The safety of Orbital Atherectomy System will be compared to rotational atherectomy by comparing the MACE rate at 1 month recorded in this study and that recorded in the Euro4C Study.	30 days