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

NCT05417022 | Unknown FDA Device

• 1 other identifier: 2021-A02662-39
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Angiography; Coronary Calcification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efficacy Endpoint : Revascularization success rate

  Until hospital discharge after index procedure, average estimated at 48 hours

• Safety Endpoint : 12 Month MACE

  12 months

• Safety endpoint : Comparison of MACE with rotational atherectomy

  30 days

Study Arms (1)

Diamondback 360TM orbital atherectomy system

Device: Diamondback 360TM orbital atherectomy system

Interventions

Diamondback 360TM orbital atherectomy system DEVICE

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

Diamondback 360TM orbital atherectomy system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who undergo an angioplasty requiring Diamondback 360TM orbital atherectomy System and who agree to participate in this study will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Recherche Cardio Vasculaire Alpes: lead

Study Sites (17)

GCS-ES Axium-Rambot

Aix-en-Provence, France

NOT YET RECRUITING

Centre Hospitalier Antibes - Juan-Les-Pins

Antibes, 06 606, France

RECRUITING

Hôpital Européen de la Roseraie

Aubervilliers, 93300, France

NOT YET RECRUITING

Centre Hospitalier d'Avignon

Avignon, France

RECRUITING

Clinique Rhône Durance

Avignon, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Pôle Santé République - ELSAN

Clermont-Ferrand, France

RECRUITING

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, France

RECRUITING

Centre Hospitalier de Haguenau

Haguenau, 67500, France

RECRUITING

Centre Hospitalier Marne la Vallée

Jossigny, 77600, France

RECRUITING

Hôpital de la Timone

Marseille, France

RECRUITING

Hôpital Privé du Confluent

Nantes, 44000, France

RECRUITING

Centre Hospitalier Universitaire de Nîmes

Nîmes, France

RECRUITING

Clinique Saint Hilaire

Rouen, France

RECRUITING

Institut Arnault Tzanck

Saint-Laurent-du-Var, 06700, France

NOT YET RECRUITING

CHU Strasbourg

Strasbourg, 67000, France

NOT YET RECRUITING

Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

Toulon, 83100, France

RECRUITING

Related Publications (13)

• 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.

  PMID: 31307929 BACKGROUND

• 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.

  PMID: 16326375 BACKGROUND

• 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.

  PMID: 20690152 BACKGROUND

• 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.

  PMID: 1617791 BACKGROUND

• 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.

  PMID: 9236427 BACKGROUND

• 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.

  PMID: 24746600 BACKGROUND

• 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.

  PMID: 24852804 BACKGROUND

• 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.

  PMID: 21183767 BACKGROUND

• 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.

  PMID: 32250249 BACKGROUND

• 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.

  PMID: 25017740 BACKGROUND

• 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.

  PMID: 24561145 BACKGROUND

• 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.

  PMID: 23460596 BACKGROUND

• 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.

  PMID: 28162989 BACKGROUND

Study Officials

• Jacques Monségu

  Groupe Hospitalier Mutualiste de Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Monségu

CONTACT

+33621273352; jacquesmonsegu@gmail.com

Angélique Grangier

CONTACT

+33476707440; agrangier.crca@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 14, 2022
• Study Start: June 15, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

FR (17)