Clinical trial NCT04556682: IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions
Official title: Intravascular Lithotripsy and Rotational Atherectomy in Treatment of Severely Calcified Coronary Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Calcification
Keywords: IVL
RA
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease who found to have severe coronary calcification during percutaneous coronary intervention.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Strategy success
timeFrame: Up to one day
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: after one year
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Assiut University
name: Amr youssef, professor
role: STUDY_CHAIR
affiliation: Leiden University Medical Center
name: Johan W Jukema, professor
role: STUDY_CHAIR
affiliation: Leiden University Medical Center
name: Iannis Karalis, Doctor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed Abdelghany, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Salma M Taha, Lecturer
role: STUDY_CHAIR
affiliation: Assiut University
name: Mohamed AA Mousa, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.