Severely Calcified Coronary Stenoses, De Novo Stenosis
Conditions
Keywords
Severely Calcified Coronary Stenoses, Intravascular Lithotripsy, percutaneous coronary intervention
Brief summary
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis. Intravascular lithotripsy (IVL), a novel approach for severely calcified coronary lesion preparation, has shown promising preliminary outcomes. Combining IVL with conventional approaches, such as Rotational atherectomy (RA), non-compliant balloons, or cutting balloons, may associated with additional benefit than conventional approaches only in terms of better stent expansion and lower long-term adverse events. This pilot randomized trial aims to investigate whether combining IVL to conventional therapy surpasses the efficacy of conventional approaches alone. The primary effectiveness endpoint is final stent expansion assessed by post-procedure optical coherence tomography (OCT), and the primary safety endpoint is target lesion failure (TVF). The trial seeks to provide valuable insights into the optimal approach for managing severely calcified coronary lesions during PCI.
Interventions
PROCEDUREIntravascular Lithotripsy
The size of the IVL balloon catheter is selected in a 1:1 ratio to the distal reference vessel diameter. The balloon catheter is then inflated to 4 atm, and 10 impulses are delivered. Subsequently, the balloon is inflated to 8 atm and then deflated to re-establish blood flow. Up to 100 impulses can be delivered, and the balloon can be repositioned within the lesion. In cases involving multiple lesions with different reference vessel diameters, various sizes of IVL balloons may be employed. If the IVL balloon catheter is unable to pass through the lesion, pre-dilatation can be performed using a smaller diameter noncompliant balloon or rotational atherectomy.
PROCEDUREConventional lesion preparation strategy
Conventional lesion preparation strategy includes the use of Compliant, noncompliant, cutting, or scoring balloons, Excimer laser coronary atherectomy, or Rotational atherectomy at the discretion of the operator.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of adding IVL to Conventional Therapy compared to Conventional Therapy only in calcified coronary lesions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Patients with acute or chronic coronary artery syndrome indicated for PCI with stenting. 2. Able to understand and provide informed consent and comply with all study procedures Angiographic Inclusion Criteria: 1. Native and de novo coronary artery disease 2. Lesion navigable by a 0.014 guidewire. 3. Target lesion is severely calcified, meeting one of the following criteria: * Presence of calcium ≥ 270°, lengths ≥ 5mm, and thickness ≥ 0.5mm at one cross-section as assessed by OCT * If the OCT catheter is unable to pass through the target lesion after dilatation due to calcification or tortuosity, and the target lesion is severely calcified on both sides of the arterial wall during angiography, with the length of the calcification \>15 mm, the lesion will be recognized as a severely calcified lesion, meeting the criteria for enrollment
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final stent expansion (%) assessed by OCT | Measured by the data collected at the end of the PCI procedure | The primary efficacy endpoint of the trial is the Final stent expansion %, defined as the minimum stent area (MSA) / mean reference lumen area assessed by OCT. |
| Target vessel failure (TVF) | 1, 12, 36, and 60 months | The primary safety endpoint of the trial is target vessel failure (TVF), defined as a non-hierarchical composite endpoint of cardiovascular death, target-vessel myocardial infarction (TV-MI), and clinically indicated target vessel revascularization (CI-TVR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular adverse events | 1, 12, 36, and 60 months | Major adverse cardiovascular events (MACE) is defined as a hierarchical composite of cardiovascular death, target-vessel myocardial infarction, clinically indicated target vessel revascularization, stent delivery failure, and suboptimal stent deployment. The between-group difference in terms of MACE will be compared using the Win Ratio approach in the abovementioned order. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stent delivery failure | Measured by the data collected at the end of the PCI procedure | — |
| Cardiac cause death | 1, 12, 36, and 60 months | — |
| Target vessel myocardial infarction (TV-MI) | 1, 12, 36, and 60 months | — |
| Clinically indicated target lesion revascularization (CI-TLR) | 1, 12, 36, and 60 months | — |
| Clinically indicated target vessel revascularization (CI-TVR) | 1, 12, 36, and 60 months | — |
| All cause death | 1, 12, 36, and 60 months | — |
| Any stroke | 1, 12, 36, and 60 months | — |
| Any MI | 1, 12, 36, and 60 months | — |
| Any revascularisation | 1, 12, 36, and 60 months | — |
| Patient-oriented composite endpoint (PoCE) | 1, 12, 36, and 60 months | Patient-oriented composite endpoint (PoCE) is defined as all-cause death, any stroke, any MI, and any clinically indicated revascularisation |
| Definite/Probable Stent thrombosis rates | 1, 12, 36, and 60 months | According to ARC-II classification |
| Peri-procedural MI | 48 hours | According to SCAI definition |
| Contrast volume | Measured by the data collected at the end of the PCI procedure | — |
| Acute gain | Measured by the data collected at the end of the PCI procedure | Acute gain is the difference between post- and pre-procedural minimal lumen diameter (MLD) as measured in (preferable) identical orthogonal views by OCT (MLDpost - MLDpre) |
| The difference between post- and pre-procedural FFR/IMR | Measured by the data collected at the end of the PCI procedure | FFR/IMR can be measured either by wire or derived from coronary angiography |
| Procedure time of the PCI | Measured by the data collected at the end of the PCI procedure | — |
| Radiation dose of the PCI | Measured by the data collected at the end of the PCI procedure | — |
| Angiographic success | Measured by the data collected at the end of the PCI procedure | Angiographic success is defined as the ability of the allocated treatment to produce residual stenosis \<20% after stenting without serious angiographic complications (severe dissection impairing flow \[type D-F\], perforation, abrupt closure, persistent slow flow, or no-reflow). |
| Strategy success | Measured by the data collected at the end of the PCI procedure | Strategy success is defined as Angiographic success without treatment crossover or stent loss |
| Clinical (Procedural) success | 1 month | Clinical (Procedural) success is defined as Device success without the occurrence of in-hospital cardiovascular death, target-vessel myocardial infarction, or clinically indicated target vessel revascularization. |
| Coronary flow velocity | Measured by the data collected at the end of the PCI procedure | Coronary flow velocity is measured by Quantitative Flow Ratio (QFR) |
| TIMI Flow | Measured by the data collected at the end of the PCI procedure | — |
| Stent malapposition | Measured by the data collected at the end of the PCI procedure | — |
| Stent volume / reference lumen volume | Measured by the data collected at the end of the PCI procedure | Assessed by OCT |
| Mean stent area / Mean reference lumen area | Measured by the data collected at the end of the PCI procedure | Assessed by OCT Assessed by OCT |
| Peri-procedural major adverse events | 30 days | Peri-procedural major adverse events were defined as a composite of the procedure of periprocedural MI, flow-limiting dissections, perforation/rupture, acute occlusion, slow-flow/no-reflow, ventricular tachycardia/ventricular fibrillation within 30 days |
| Calcium fracture | Measured by the data collected at the end of the PCI procedure | — |
| Suboptimal stent deployment | Measured by the data collected at the end of the PCI procedure | Suboptimal stent deployment is defined as fulfilling any of the following criteria: minimum stent area (MSA) ≤4.5mm2 (by OCT), MSA/mean reference lumen area ≤80%, flow-limiting dissections, or incomplete stent apposition (axial distance ≥0.4 mm and length ≥1 mm) |
Countries
China
Contacts
Primary ContactChao Gao,, M.D, Ph.D
Backup ContactRuining Zhang, BSc
Outcome results
None listed