AngiographyREFORCENCT05417022
Safety and Efficacy Evaluation of Orbital Atherectomy System in de Novo Calcified Lesions
An observational study of Angiography and Coronary Calcification, run by Centre Recherche Cardio Vasculaire Alpes at 17 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiography, Coronary Calcification
- What is being tested?
- Diamondback 360TM orbital atherectomy system
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 17 sitesFrance
- Study dates
- 15 Jun 2022to 1 Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
GCS-ES Axium-Rambot
Aix-en-Provence
Marc Silvestri, 04 42 95 73 10, drmsilvestri@gmail.com
- Recruiting
Centre Hospitalier Antibes - Juan-Les-Pins
Antibes, 06 606
Anne Bellemain-Appaix, 04 97 24 75 44, annebellem1@hotmail.fr
- Not yet recruiting
Hôpital Européen de la Roseraie
Aubervilliers, 93300
Hakim Ben-Amer, 01 48 39 40 62, h.benamer@angio-icps.com
- Recruiting
Centre Hospitalier d'Avignon
Avignon
Marine Quillot, +33476707440, marine.quillot@gmail.com
- Not yet recruiting
Clinique Rhône Durance
Avignon
Jean-Pascal Peyre, +33476707440, jpascal.peyre@gmail.com
- Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand
Pascal Motreff, +33473751421, pmotreff@chu-clermontferrand.fr
- Recruiting
Pôle Santé République - ELSAN
Clermont-Ferrand
Nicolas Durel, +33473994355, dureln@yahoo.fr
- Recruiting
Groupe Hospitalier Mutualiste de Grenoble
Grenoble
Jacques Monségu, +33621273352, jacquesmonsegu@gmail.com
Angélique Grangier, +33476707440, agrangier.crca@gmail.com
- Recruiting
Centre Hospitalier de Haguenau
Haguenau, 67500
Pierre Leddet, 03 88 06 35 57, Pierre.leddet@ch-haguenau.fr
- Recruiting
Centre Hospitalier Marne la Vallée
Jossigny, 77600
Simon Elhadad, 01 61 10 63 91, selhadad@ghef.fr
- Recruiting
Hôpital de la Timone
Marseille
Pierre Deharo, +33685028218, deharopierre@gmail.com
- Recruiting
Hôpital Privé du Confluent
Nantes, 44000
Ashok Tirouvanziam, 02 28 25 51 15, atirouvanziam@gmail.com
- Recruiting
Centre Hospitalier Universitaire de Nîmes
Nîmes
Luc Cornillet, +33466683116, luc_cornillet@hotmail.com
- Recruiting
Clinique Saint Hilaire
Rouen
Alexandre Canville, +33235086621, acanville@clinique-sainthilaire.fr
- Not yet recruiting
Institut Arnault Tzanck
Saint-Laurent-du-Var, 06700
Léo Cuénin, 04 92 27 37 37, leo.cuenin@gmail.com
- Not yet recruiting
CHU Strasbourg
Strasbourg, 67000
Olivier Morel, 03 69 55 06 36, olivier.morel@chru-strasbourg.fr
- Recruiting
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Toulon, 83100
Gonzalo Quaino, 04 94 14 59 55, gonzalo.quaino@ch-toulon.fr
About this study
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
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.
Read the detailed 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.
- Conditions
- Angiography, Coronary Calcification
- Being tested
- Diamondback 360TM orbital atherectomy system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diamondback 360TM orbital atherectomy systemDevice
Use of the Diamondback 360TM orbital atherectomy system in the preparation of calcified coronary lesions before implantation of a coronary endoprothesis
| Study group | Role | What they receive |
|---|---|---|
| Diamondback 360TM orbital atherectomy system | Not described Receives: Device: Diamondback 360TM orbital atherectomy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
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.
Measured: Until hospital discharge after index procedure, average estimated at 48 hours
Safety Endpoint : 12 Month MACE
See MACE definition in the primary outcome.
Measured: 12 months
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start15 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AngiographyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centre Recherche Cardio Vasculaire Alpes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Monségu, Principal investigator, Groupe Hospitalier Mutualiste de Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417022
- Sponsor's protocol ID
- 2021-A02662-39
- Acronym
- REFORCE
- Status last verified
- Dec 2023
- First submitted
- 13 May 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 31307929Mosseri 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.
PubMed 16326375Onuma 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.
PubMed 20690152Fitzgerald 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.
PubMed 1617791Moussa 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.
PubMed 9236427Bhatt 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.
PubMed 24746600Chambers 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.
PubMed 24852804Benezet 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.
PubMed 21183767Bouisset 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.
PubMed 32250249Kobayashi 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.
PubMed 25017740Genereux 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.
PubMed 24561145Parikh 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.
PubMed 23460596Lee 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.
PubMed 28162989
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05417022
- Acronym / sponsor ID
- REFORCE / 2021-A02662-39
- Conditions
- Angiography, Coronary Calcification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Recherche Cardio Vasculaire AlpesUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 14 Jun 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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diamondback 360TM orbital atherectomy system | – | Device: Diamondback 360TM orbital atherectomy system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Diamondback 360TM orbital atherectomy systemUse of the Diamondback 360TM orbital atherectomy system in the preparation of calcified coronary lesions before implantation of a coronary endoprothesis | Device | Diamondback 360TM orbital atherectomy system |
Primary outcome
Safety Endpoint : Major Adverse Cardiac Event (MACE)
Time frame: 30 days
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.
3 secondary outcomes
Efficacy Endpoint : Revascularization success rate
Time frame: Until hospital discharge after index procedure, average estimated at 48 hours
Safety Endpoint : 12 Month MACE
Time frame: 12 months
Safety endpoint : Comparison of MACE with rotational atherectomy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 31307929Sturm 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.
- Background: PubMed 16326375Mosseri 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.
- Background: PubMed 20690152Onuma 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.
- Background: PubMed 1617791Fitzgerald 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.
- Background: PubMed 9236427Moussa 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.
- Background: PubMed 24746600Bhatt 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.
- Background: PubMed 24852804Chambers 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.
- Background: PubMed 21183767Benezet 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.
- Background: PubMed 32250249Bouisset 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.
- Background: PubMed 25017740Kobayashi 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.
- Background: PubMed 24561145Genereux 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.
- Background: PubMed 23460596Parikh 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.
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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.
Jacques Monségu principal investigator
Groupe Hospitalier Mutualiste de Grenoble
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angiography and Coronary Calcification, run by Centre Recherche Cardio Vasculaire Alpes at 17 sites 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 7 inclusion and 6 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 Jacques Monségu (+33621273352, jacquesmonsegu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint : Major Adverse Cardiac Event (MACE) (time frame: 30 days). 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 NCT05417022, which also lists 13 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 20 Dec 2023.