Coronary CalcificationNCT04556682

IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions

An observational study of Coronary Calcification, run by Assiut University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Calcification
What is being tested?: Rotational atherectomy and Intravascular lithotripsy
Type of treatment: Medical device
How many people: 101 participants
Where: 1 siteNetherlands
Study dates: 1 May 2021to 25 Feb 2022
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
No healthy volunteers
Adult, Older adult

Study population: Patients with coronary artery disease who found to have severe coronary calcification during percutaneous coronary intervention.

Who may be able to join

Patients aged >18 years undergoing PCI because of stable angina (uncontrolled symptoms on optimal medical treatment) or post stabilized acute coronary syndrome (ACS).
Patients have severe calcification: defined either angiographically or by OCT (or IVUS) as calcium arch >180º in at least one cross section , calcium length >5mm, calcium thickness >0.5 mm (2, 6).
Vessel diameter ≥2.5mm and ≤4.0mm .
Heavily calcified lesion length less than 40mm.
All patients must have been discussed in the heart team of the hospital and accepted for coronary intervention

Who cannot join

Severe coronary calcification with lesion uncrossable from a balloon.
PCIs in the setting of STEMI or NSTEMI with persistent complains.
Patients in cardiogenic shock.
Heart failure New York Heart Association (NYHA) class IV.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Leiden University Medical Center
Leiden

Other trials in Netherlands

About this study

Official title: Intravascular Lithotripsy and Rotational Atherectomy in Treatment of Severely Calcified Coronary Lesions

Read the detailed description

Coronary artery calcification (CAC) occurs in over 90% of men and 67% of women older than 70 years old .

Severe coronary calcification may be present in about 20% of patients undergoing percutaneous coronary intervention (PCI) .

Coronary calcification may impair stent delivery and expansion and damage the polymer/drug coating, resulting in impaired drug delivery and predispose to restenosis and stent thrombosis.

Intravascular imaging as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are good tools to assess calcium burden, distribution and thickness. Among the two imaging techniques, OCT was found to be more accurate than IVUS in defining calcium burden, calcium area , thickness and calcium length.

Rotational atherectomy (RA) as a method of severely calcified lesions modification before Drug-Eluting-Stent (DES) implantation has shown good outcomes in recent studies. However, its efficacy is reduced in presence of deep calcification.

Recently, intravascular lithotripsy (IVL) has been introduced as a novel modality for severely calcified coronary lesion preparation with good preliminary outcomes .

Currently the two techniques are regularly being used in combination in order to achieve optimal results . Whether IVL is a method equally good (or superior) to rotablation in cases where anatomy does not exclude the use of either technique (for example balloon-crossable, heavily calcified lesions) has not yet been discussed.

Conditions: Coronary Calcification
Being tested: Rotational atherectomy, Intravascular lithotripsy
Keywords: IVL, RA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rotational atherectomyDevice
Device used for severely calcified coronary lesion preparation before stent implantation.
Intravascular lithotripsyDevice
Device used for severely calcified coronary lesion preparation before stent implantation.

Study groups in NCT04556682
Study group	Role	What they receive
Patients who underwent Rotational atherectomy (RA)		The device contains rapidly rotating burr that is coated with microscopic diamond chips, which debulks the calcified plaque by grinding the calcified atheroma into small particles facilitating stent passage and expansion. Both transfemoral or transradial approach can be used. Regular PCI guidewire can be used to cross the often complex anatomy then switching to a rotablation dedicated guidewire over a microcatheter. Burr sizes vary from 1.25mm up to 1.75mm (in certain cases bigger calibers may also be used) aiming to achieve plaque modification . Receives: Device: Rotational atherectomy
Patients who underwent Intravascular lithotripsy (IVL)		The Coronary IVL System consists of an IVL Balloon Catheter with 2 integrated emitters, a Lithotripsy Generator, and a Connector Cable. These emitters create sonic pressure waves that selectively fracture calcium and alter vessel compliance facilitating stent passage and expansion. It is available in 2.5- to 4.0-mm diameters and 12 mm in length, with an inflation pressure of 4 atm used for delivering the treatment. Every catheter can emit a maximum of 80 pulses at a rate of one pulse per second. The IVL balloon catheter is chosen based on the reference lumen of the vessel and after pre-dilatation of the lesion (preferably with a non-compliant balloon) 10-30 pulses are given, usually with interval deflation to allow distal perfusion. If the lesion exceeds the 12 mm balloon length, the balloon can be repositioned and the IVL repeated . Receives: Device: Intravascular lithotripsy

What is being measured

The primary outcome is the main question the study is designed to answer.

Strategy success
less than 20% in-stent residual stenosis of the target lesion and no postprocedural complications as no-reflow, dissection or perforation.
Measured: Up to one day

Secondary outcomes (1)

Major Adverse Cardiac Events
composite of Death, stroke, myocardial infarction, stent thrombosis, target vessel revascularization, and hospitalization at long term follow up
Measured: after one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202125 Feb 2022

First posted21 Sep 2020
Study start1 May 2021
Primary completion15 Dec 2021
Study completion25 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Coronary CalcificationStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe sponsor's other registered studies.
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: Retrospective
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04556682
Sponsor's protocol ID: IVL and RA in calcificaion
Status last verified: Jul 2022
First submitted: 11 Sep 2020
Last updated: 2 Aug 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Liu W, Zhang Y, Yu CM, Ji QW, Cai M, Zhao YX, Zhou YJ. Current understanding of coronary artery calcification. J Geriatr Cardiol. 2015 Nov;12(6):668-75. doi: 10.11909/j.issn.1671-5411.2015.06.012.
PubMed 26788045
Kassimis G, Didagelos M, De Maria GL, Kontogiannis N, Karamasis GV, Katsikis A, Sularz A, Karvounis H, Kanonidis I, Krokidis M, Ziakas A, Banning AP. Shockwave Intravascular Lithotripsy for the Treatment of Severe Vascular Calcification. Angiology. 2020 Sep;71(8):677-688. doi: 10.1177/0003319720932455. Epub 2020 Jun 22.
PubMed 32567327
Bourantas CV, Zhang YJ, Garg S, Iqbal J, Valgimigli M, Windecker S, Mohr FW, Silber S, Vries Td, Onuma Y, Garcia-Garcia HM, Morel MA, Serruys PW. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014 Aug;100(15):1158-64. doi: 10.1136/heartjnl-2013-305180. Epub 2014 May 20.
PubMed 24846971
De Maria GL, Scarsini R, Banning AP. Management of Calcific Coronary Artery Lesions: Is it Time to Change Our Interventional Therapeutic Approach? JACC Cardiovasc Interv. 2019 Aug 12;12(15):1465-1478. doi: 10.1016/j.jcin.2019.03.038.
PubMed 31395217
Lee MS, Shah N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol. 2016 Apr;28(4):160-7. Epub 2015 Aug 25.
PubMed 26301561
Barbato E, Carrie D, Dardas P, Fajadet J, Gaul G, Haude M, Khashaba A, Koch K, Meyer-Gessner M, Palazuelos J, Reczuch K, Ribichini FL, Sharma S, Sipotz J, Sjogren I, Suetsch G, Szabo G, Valdes-Chavarri M, Vaquerizo B, Wijns W, Windecker S, de Belder A, Valgimigli M, Byrne RA, Colombo A, Di Mario C, Latib A, Hamm C; European Association of Percutaneous Cardiovascular Interventions. European expert consensus on rotational atherectomy. EuroIntervention. 2015 May;11(1):30-6. doi: 10.4244/EIJV11I1A6.
PubMed 25982648
Kassimis G, Raina T, Kontogiannis N, Patri G, Abramik J, Zaphiriou A, Banning AP. How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy. Cardiovasc Revasc Med. 2019 Dec;20(12):1172-1183. doi: 10.1016/j.carrev.2019.01.010. Epub 2019 Jan 10.
PubMed 30711477
Aksoy A, Salazar C, Becher MU, Tiyerili V, Weber M, Jansen F, Sedaghat A, Zimmer S, Leick J, Grube E, Gonzalo N, Sinning JM, Escaned J, Nickenig G, Werner N. Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry. Circ Cardiovasc Interv. 2019 Nov;12(11):e008154. doi: 10.1161/CIRCINTERVENTIONS.119.008154. Epub 2019 Nov 11.
PubMed 31707803
Jurado-Roman A, Gonzalvez A, Galeote G, Jimenez-Valero S, Moreno R. RotaTripsy: Combination of Rotational Atherectomy and Intravascular Lithotripsy for the Treatment of Severely Calcified Lesions. JACC Cardiovasc Interv. 2019 Aug 12;12(15):e127-e129. doi: 10.1016/j.jcin.2019.03.036. Epub 2019 Jul 17. No abstract available.
PubMed 31326422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Calcification trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravascular Lithotripsy and Rotational Atherectomy in Treatment of Severely Calcified Coronary Lesions
ClinicalTrials.gov ID: NCT04556682
Acronym / sponsor ID: IVL and RA in calcificaion
Conditions: Coronary Calcification
Keywords: IVL, RA
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 1 May 2021 (actual)
Primary completion: 15 Dec 2021 (actual)
Study completion: 25 Feb 2022 (actual)
First posted: 21 Sep 2020 (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.

Detailed description

Coronary artery calcification (CAC) occurs in over 90% of men and 67% of women older than 70 years old .

Severe coronary calcification may be present in about 20% of patients undergoing percutaneous coronary intervention (PCI) .

Coronary calcification may impair stent delivery and expansion and damage the polymer/drug coating, resulting in impaired drug delivery and predispose to restenosis and stent thrombosis.

Recently, intravascular lithotripsy (IVL) has been introduced as a novel modality for severely calcified coronary lesion preparation with good preliminary outcomes .

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Patients who underwent Rotational atherectomy (RA)	–	Device: Rotational atherectomyThe device contains rapidly rotating burr that is coated with microscopic diamond chips, which debulks the calcified plaque by grinding the calcified atheroma into small particles facilitating stent passage and expansion. Both transfemoral or transradial approach can be used. Regular PCI guidewire can be used to cross the often complex anatomy then switching to a rotablation dedicated guidewire over a microcatheter. Burr sizes vary from 1.25mm up to 1.75mm (in certain cases bigger calibers may also be used) aiming to achieve plaque modification .
Patients who underwent Intravascular lithotripsy (IVL)	–	Device: Intravascular lithotripsyThe Coronary IVL System consists of an IVL Balloon Catheter with 2 integrated emitters, a Lithotripsy Generator, and a Connector Cable. These emitters create sonic pressure waves that selectively fracture calcium and alter vessel compliance facilitating stent passage and expansion. It is available in 2.5- to 4.0-mm diameters and 12 mm in length, with an inflation pressure of 4 atm used for delivering the treatment. Every catheter can emit a maximum of 80 pulses at a rate of one pulse per second. The IVL balloon catheter is chosen based on the reference lumen of the vessel and after pre-dilatation of the lesion (preferably with a non-compliant balloon) 10-30 pulses are given, usually with interval deflation to allow distal perfusion. If the lesion exceeds the 12 mm balloon length, the balloon can be repositioned and the IVL repeated .

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with coronary artery disease who found to have severe coronary calcification during percutaneous coronary intervention.

Key inclusion criteria (5 listed)

Patients aged >18 years undergoing PCI because of stable angina (uncontrolled symptoms on optimal medical treatment) or post stabilized acute coronary syndrome (ACS).
Patients have severe calcification: defined either angiographically or by OCT (or IVUS) as calcium arch >180º in at least one cross section , calcium length >5mm, calcium thickness >0.5 mm (2, 6).
Vessel diameter ≥2.5mm and ≤4.0mm .
Heavily calcified lesion length less than 40mm.
All patients must have been discussed in the heart team of the hospital and accepted for coronary intervention

Key exclusion criteria (4 listed)

Severe coronary calcification with lesion uncrossable from a balloon.
PCIs in the setting of STEMI or NSTEMI with persistent complains.
Patients in cardiogenic shock.
Heart failure New York Heart Association (NYHA) class IV.

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
Rotational atherectomyDevice used for severely calcified coronary lesion preparation before stent implantation.	Device	Patients who underwent Rotational atherectomy (RA)
Intravascular lithotripsyDevice used for severely calcified coronary lesion preparation before stent implantation.	Device	Patients who underwent Intravascular lithotripsy (IVL)

Primary outcome

Strategy success
Time frame: Up to one day
less than 20% in-stent residual stenosis of the target lesion and no postprocedural complications as no-reflow, dissection or perforation.

1 secondary outcome

Major Adverse Cardiac Events
Time frame: after one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
Background: PubMed 26788045Liu W, Zhang Y, Yu CM, Ji QW, Cai M, Zhao YX, Zhou YJ. Current understanding of coronary artery calcification. J Geriatr Cardiol. 2015 Nov;12(6):668-75. doi: 10.11909/j.issn.1671-5411.2015.06.012.
Background: PubMed 32567327Kassimis G, Didagelos M, De Maria GL, Kontogiannis N, Karamasis GV, Katsikis A, Sularz A, Karvounis H, Kanonidis I, Krokidis M, Ziakas A, Banning AP. Shockwave Intravascular Lithotripsy for the Treatment of Severe Vascular Calcification. Angiology. 2020 Sep;71(8):677-688. doi: 10.1177/0003319720932455. Epub 2020 Jun 22.
Background: PubMed 24846971Bourantas CV, Zhang YJ, Garg S, Iqbal J, Valgimigli M, Windecker S, Mohr FW, Silber S, Vries Td, Onuma Y, Garcia-Garcia HM, Morel MA, Serruys PW. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014 Aug;100(15):1158-64. doi: 10.1136/heartjnl-2013-305180. Epub 2014 May 20.
Background: PubMed 31395217De Maria GL, Scarsini R, Banning AP. Management of Calcific Coronary Artery Lesions: Is it Time to Change Our Interventional Therapeutic Approach? JACC Cardiovasc Interv. 2019 Aug 12;12(15):1465-1478. doi: 10.1016/j.jcin.2019.03.038.
Background: PubMed 26301561Lee MS, Shah N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol. 2016 Apr;28(4):160-7. Epub 2015 Aug 25.
Background: PubMed 25982648Barbato E, Carrie D, Dardas P, Fajadet J, Gaul G, Haude M, Khashaba A, Koch K, Meyer-Gessner M, Palazuelos J, Reczuch K, Ribichini FL, Sharma S, Sipotz J, Sjogren I, Suetsch G, Szabo G, Valdes-Chavarri M, Vaquerizo B, Wijns W, Windecker S, de Belder A, Valgimigli M, Byrne RA, Colombo A, Di Mario C, Latib A, Hamm C; European Association of Percutaneous Cardiovascular Interventions. European expert consensus on rotational atherectomy. EuroIntervention. 2015 May;11(1):30-6. doi: 10.4244/EIJV11I1A6.
Background: PubMed 30711477Kassimis G, Raina T, Kontogiannis N, Patri G, Abramik J, Zaphiriou A, Banning AP. How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy. Cardiovasc Revasc Med. 2019 Dec;20(12):1172-1183. doi: 10.1016/j.carrev.2019.01.010. Epub 2019 Jan 10.
Background: PubMed 31707803Aksoy A, Salazar C, Becher MU, Tiyerili V, Weber M, Jansen F, Sedaghat A, Zimmer S, Leick J, Grube E, Gonzalo N, Sinning JM, Escaned J, Nickenig G, Werner N. Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry. Circ Cardiovasc Interv. 2019 Nov;12(11):e008154. doi: 10.1161/CIRCINTERVENTIONS.119.008154. Epub 2019 Nov 11.
Background: PubMed 31326422Jurado-Roman A, Gonzalvez A, Galeote G, Jimenez-Valero S, Moreno R. RotaTripsy: Combination of Rotational Atherectomy and Intravascular Lithotripsy for the Treatment of Severely Calcified Lesions. JACC Cardiovasc Interv. 2019 Aug 12;12(15):e127-e129. doi: 10.1016/j.jcin.2019.03.036. Epub 2019 Jul 17. No abstract available.
High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary LesionsLink provided by the sponsor.
Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary StenosesLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Amr youssef, professor study chair

Assiut University

Johan W Jukema, professor study chair

Leiden University Medical Center

Iannis Karalis, Doctor study director

Leiden University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Calcification, run by Assiut University at 1 site in Netherlands.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 2 Aug 2022. 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 Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Strategy success (time frame: Up to one day). 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 NCT04556682, which also lists 9 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 2 Aug 2022.