Coronary Artery Disease, Coronary Artery Calcification
Conditions
Keywords
CAD
Brief summary
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.
Detailed 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.
Interventions
Lithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting.
Sponsors
Bolt Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized, single-arm, multicenter, interventional study in adults (≥18 years of age) with de novo, calcified, stenotic coronary artery lesions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | Within 30 days following procedure | Freedom from major adverse cardiac events (MACE) within 30 days following the index procedure. |
| Primary Effectiveness Endpoint | Immediately after the intervention/procedure/surgery | Procedural success defined as successful stent delivery with a final residual stenosis \<50% (assessed by angiographic core laboratory) and freedom from in-hospital MACE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success | Immediately after the intervention/procedure/surgery | The ability to deliver the Bolt IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. |
| Angiographic success (at <50%) | Immediately after the intervention/procedure/surgery | Stent delivery with \<50% final residual stenosis and without serious angiographic complications. |
| Procedural success | Immediately after the intervention/procedure/surgery | Stent delivery with a final residual stenosis ≤30% and without in-hospital MACE. |
| Angiographic success (at ≤30%) | Immediately after the intervention/procedure/surgery | Stent delivery with ≤30% final residual stenosis and without serious angiographic complications. |
| Serious angiographic complications | Immediately after the intervention/procedure/surgery | Severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. |
| MACE | within 6, 12, and 24 months. | MACE within 6, 12, and 24 months. |
| Target lesion failure (TLF) | 30 days, 6 months, 12 months, and 24 months | 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. |
| 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 | Periprocedure, within 30 days, 6 months, 12 months, and 24 months | 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). |
Countries
Belgium, Denmark, Germany, Lithuania, Netherlands, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORMargaret McEntegart, MD, PhD
NY Presbyterian Hospital/Columbia University Medical Center
PRINCIPAL_INVESTIGATORNicholas van Mieghem, MD, PhD
Erasmus Medical Center
Outcome results
None listed