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Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

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ClinicalTrials.gov Identifier: NCT04698902
Recruitment Status : Recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Nieves Gonzalo, Fundacion Investigacion Interhospitalaria Cardiovascular

Brief Summary:

Calcified coronary artery disease is a frequently encountered problem that can lead to poorer outcomes for patients undergoing PCI. Recently, intravascular lithotripsy has become available for the treatment of callcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored.

This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain examining the effect of intravasuclar lithotripsy in varying calcium patterns. 100 patients wll be enrolled. Optical coherence tomography will be used to assess the effect of intravascular lithotripsy on varying calcium patterns (concentric, eccentric and nodular).


Condition or disease Intervention/treatment
Coronary Artery Disease Intracoronary Lithotripsy Optical Coherence Tomography Percutaneous Coronary Intervention Calcification Stent Device: Intracoronary lithotripsy

Detailed Description:

Calcified coronary artery disease continues to present a challenge for Interventional Cardiologists. Moderate calcification is found in over 25% of coronary artery lesions planned for percutaneous coronary intervention (PCI). Outcomes for patients undergoing PCI to calcified lesions have been shown to be consistently poorer than in non-calcified lesions. Recently, intravascular lithotripsy has become available for the treatment of calcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored.

This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain. Patients with an indication of PCI and with a significant calcium burden requiring modification will be invited to participate. PCI procedures will be performed via either radial or femoral access as deemed appropriate by the operator and in accordance with local protocols. Intravascular imaging using OCT will be performed prior to calcium modification to define the pattern of calcium, after calcium modification to assess the effectiveness of IVL therapy and after stent implantation to assess stent expansion.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Group/Cohort Intervention/treatment
Circumferential calcification
Patients with circumferential pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium >180 degrees)
Device: Intracoronary lithotripsy
Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall.

Eccentric calcification
Patients with an eccentric pattern of coronary artery calcification by OCT (Optical coherence tomography) assessment (arc of calcium <180 degrees)
Device: Intracoronary lithotripsy
Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall.

Nodular calcification
Patients with calcium nodules identified by OCT (Optical coherence tomography) assessment
Device: Intracoronary lithotripsy
Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall.




Primary Outcome Measures :
  1. Percentage of lesions with Calcium Fractures [ Time Frame: At the time of percutaneous coronary intervention ]
    Percentage of lesions showing calcium modification (fractures) after intravascular lithotripsy (IVL) in nodular eccentric and concentric calcium patterns


Secondary Outcome Measures :
  1. Number of calcium fractures [ Time Frame: At the time of percutaneous coronary intervention ]
    Number of calcium fractures visible on OCT after IVL treatment

  2. Number of quadrants with calcium fractures [ Time Frame: At the time of percutaneous coronary intervention ]
    Number of quadrants with calcium fractures after IVL treatment as assessed by OCT

  3. Calcium modification in eccentric versus concentric calcium [ Time Frame: At the time of percutaneous coronary intervention ]
    Percentage of lesions with calcium arc <180 versus >180 degrees with fractures as assessed by OCT

  4. Stent expansion [ Time Frame: At the time of percutaneous coronary intervention ]
    Percentage stent expansion in patients with and without calcium modification (fractures) after application of IVL

  5. Stent symmetry [ Time Frame: At the time of percutaneous coronary intervention ]
    Stent symmetry index in patients with and without calcium modification (fractures) after IVL application

  6. Stent symmetry [ Time Frame: At the time of percutaneous coronary intervention ]
    Stent symmetry index in patients with concentric versus eccentric calcification



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with calcified coronary artery disease planned for percutaneous coronary intervention and stenting with the use of intravascular lithotripsy for calcium modification prior to stenting.
Criteria

Inclusion Criteria:

  • Patients >18 years of age
  • Patients with an indication for PCI (ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of >50% de novo severely calcified coronary stenosis that requires IVL treatment.

Exclusion Criteria:

  • Patients unwilling or unable to sign informed consent for the procedure
  • Patients with severe peripheral vascular disease limiting vascular access to the extent that it is unsafe to perform the procedure
  • Patients with severe renal dysfunction (eGFR <15mls/min and not receiving dialysis)
  • Treatment of vessels < 2.5mm diameter which are not amenable to IVL treatment or OCT assessment.
  • Treatment of lesions located very distally in the coronary vessel where the OCT catheter may not reach.
  • Inability to cross the lesion with the OCT catheter due to very severe stenosis or severe vessel tortuosity.
  • Ostial left main stem or right coronary artery lesions which may be difficult to visualise by OCT
  • Patients requiring concomitant use of rotational or orbital atherectomy of LASER.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698902


Contacts
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Contact: Nieves Gonzalo, MD PhD 0034913303000 ext 3283 nieves_gonzalo@yahoo.es
Contact: Javier Escaned, MD PhD 0034913303000 ext 3283 escaned@secardiologia.es

Locations
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Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Nieves Gonzalo, MD PhD    0034913303000 ext 3282    nieves_gonzalo@yahoo.es   
Contact: Javier Escaned, MD PhD    0034913303000 ext 3282    escaned@secardiologia.es   
Sub-Investigator: Angela McInerney, MD         
Sub-Investigator: Alejandro Travieso Gonzalez, MD         
Sponsors and Collaborators
Fundacion Investigacion Interhospitalaria Cardiovascular
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Responsible Party: Nieves Gonzalo, Dr., Fundacion Investigacion Interhospitalaria Cardiovascular
ClinicalTrials.gov Identifier: NCT04698902    
Other Study ID Numbers: 20/599-E
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases