NCT04556682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

September 11, 2020

Last Update Submit

July 30, 2022

Conditions

Coronary Calcification

Keywords

IVLRA

Outcome Measures

Primary Outcomes (1)

  • Strategy success

    less than 20% in-stent residual stenosis of the target lesion and no postprocedural complications as no-reflow, dissection or perforation.

    Up to one day

Secondary Outcomes (1)

  • Major Adverse Cardiac Events

    after one year

Study Arms (2)

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 .

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 .

Device: Intravascular lithotripsy

Interventions

Rotational atherectomyDEVICE

Device used for severely calcified coronary lesion preparation before stent implantation.

Patients who underwent Rotational atherectomy (RA)
Intravascular lithotripsyDEVICE

Device used for severely calcified coronary lesion preparation before stent implantation.

Patients who underwent Intravascular lithotripsy (IVL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

Location

Related Publications (9)

  • 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.

    PMID: 26788045BACKGROUND

  • 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.

    PMID: 32567327BACKGROUND

  • 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.

    PMID: 24846971BACKGROUND

  • 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.

    PMID: 31395217BACKGROUND

  • 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.

    PMID: 26301561BACKGROUND

  • 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.

    PMID: 25982648BACKGROUND

  • 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.

    PMID: 30711477BACKGROUND

  • 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.

    PMID: 31707803BACKGROUND

  • 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.

    PMID: 31326422BACKGROUND

MeSH Terms

Interventions

Atherectomy, Coronary

Intervention Hierarchy (Ancestors)

AtherectomyAngioplastyCatheterizationTherapeuticsMyocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresVascular Surgical ProceduresPercutaneous Coronary InterventionMinimally Invasive Surgical ProceduresThoracic Surgical ProceduresInvestigative Techniques

Study Officials

  • Amr youssef, professor

    Assiut University

    STUDY CHAIR

  • Johan W Jukema, professor

    Leiden University Medical Center

    STUDY CHAIR

  • Iannis Karalis, Doctor

    Leiden University Medical Center

    STUDY DIRECTOR

  • Mohamed Abdelghany, professor

    Assiut University

    STUDY CHAIR

  • Salma M Taha, Lecturer

    Assiut University

    STUDY CHAIR

  • Mohamed AA Mousa, Doctor

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 21, 2020

Study Start

May 1, 2021

Primary Completion

December 15, 2021

Study Completion

February 25, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)