Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

Coronary Artery Disease Clinical Trial

— FRACTURE  

Official title:

Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181240
• Other study ID #: CR-005614
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: March 20, 2026

Study information

• Verified date: March 2024
• Source: Bolt Medical
• Contact: Timothy E. Meyer, PhD
• Phone: +1 760-392-3963
• Email: timothy[@]boltmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.

Description:

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers with the Bolt Intravascular Lithotripsy System that was designed to percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium prior to full balloon dilatation at low pressures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 20, 2026
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Subject is =18 years of age;

• Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI);

• For patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (ULN) within 12 hours prior to the study procedure;

• For patients with stable ischemic heart disease, CK-MB will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (ULN);

• Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with:

• Stenosis of =70% and <l00%; or

• Stenosis =50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value =0.80, or iFR <0.90, or IVUS or OCT minimum lumen area =4.0 mm2;

• Evidence of calcification at the target lesion site by

• angiography, with fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or

• Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), with presence of =270 degrees of calcium on at least 1 cross section;

• Ability to pass a 0.014" guidewire across the lesion.

Key Exclusion Criteria:

• Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure;

• New York Heart Association (NYHA) class III or IV heart failure at time of index procedure;

• Prospective need for hemodynamic support, i.e., IABP or Impella;

• Chronic kidney disease with serum creatinine >2.5 mg/dL, eGFR <30 mL/min/1.73m2, or on chronic dialysis;

• Unprotected left main diameter stenosis >50%;

• Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º;

• Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion;

• Chronic Total Occlusion;

• Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft;

Related Conditions & MeSH terms

• Coronary Artery Calcification
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Intravascular lithotripsy
Lithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam
United Kingdom	Royal Free Hospital	London
United Kingdom	St George's University of London	London
United Kingdom	St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Bolt Medical

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Freedom from major adverse cardiac events (MACE) within 30 days following the index procedure.	Within 30 days following procedure
Primary	Primary Effectiveness Endpoint	Procedural success defined as successful stent delivery with a final residual stenosis <50% (assessed by angiographic core laboratory) and freedom from in-hospital MACE.	Immediately after the intervention/procedure/surgery
Secondary	Device success	The ability to deliver the Bolt IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL.	Immediately after the intervention/procedure/surgery
Secondary	Angiographic success (at <50%)	Stent delivery with <50% final residual stenosis and without serious angiographic complications.	Immediately after the intervention/procedure/surgery
Secondary	Procedural success	Stent delivery with a final residual stenosis =30% and without in-hospital MACE.	Immediately after the intervention/procedure/surgery
Secondary	Angiographic success (at =30%)	Stent delivery with =30% final residual stenosis and without serious angiographic complications.	Immediately after the intervention/procedure/surgery
Secondary	Serious angiographic complications	Severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.	Immediately after the intervention/procedure/surgery
Secondary	MACE	MACE within 6, 12, and 24 months.	within 6, 12, and 24 months.
Secondary	Target lesion failure (TLF)	Cardiac death, target vessel myocardial infarction (TV-MI) (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods at 30 days, 6 months, 12 months, and 24 months.	30 days, 6 months, 12 months, and 24 months
Secondary	All deaths, cardiac deaths, MIs, TV-MIs, procedural and nonprocedural MIs, ID-TVRs, ID-TLRs, non-ID-TLRs, non-ID-TVRs, all revascularizations (ID and non-ID), and stent thrombosis	All deaths, cardiac deaths, MIs, TV-MIs, procedural and nonprocedural MIs, ID-TVRs, ID-TLRs, non-ID-TLRs, non-ID-TVRs, all revascularizations (ID and non-ID), and stent thrombosis (Academic Research Consortium (ARC) definite, probable, definite or probable).	Periprocedure, within 30 days, 6 months, 12 months, and 24 months