Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

De Novo Stenosis Clinical Trial

— REC-CHIPCAC  

Official title:

Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238518
• Other study ID #: KY20232390-C-1
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Xijing Hospital
• Contact: Chao Gao,, M.D, Ph.D
• Phone: +86-18629551066
• Email: woshigaochao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Exclusion Criteria:

1. Patients under 18 years of age.

2. Incapable of providing informed consent.

3. Female patients who are pregnant or nursing (a pregnancy test must be conducted within 7 days before the index procedure for women of childbearing potential, as per local practice).

4. Concurrent medical conditions with a life expectancy of less than 1 year.

5. Hemodynamic instability.

6. Known contraindications to medications such as Heparin, anticoagulation, antiplatelet drugs, or contrast.

7. Active bleeding.

8. New-onset stroke or transient ischemic attack (TIA) within 90 days prior to enrollment.

9. Severe renal dysfunction (eGFR = 30 ml/min).

10. Patients scheduled to undergo cardiac intervention or cardiac surgery within 30 days of the index procedure.

11. Recent ST-segment elevation myocardial infarction (STEMI) within 7 days or recent cardiogenic shock.

12. Lesions located in surgical conduits.

Angiographic Exclusion Criteria:

1. Target vessel exhibiting C-F type dissection.

2. Thrombosis observed by angiography or OCT.

3. Presence of an aneurysm within 10 mm of the target lesion.

4. Left main ostial lesion

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Stenosis
• De Novo Stenosis

Intervention

Procedure:
• Intravascular 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.
• Conventional 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.

Locations

Country	Name	City	State
China	Ling Tao	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Suboptimal stent deployment	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)	Measured by the data collected at the end of the PCI procedure
Other	Stent delivery failure		Measured by the data collected at the end of the PCI procedure
Other	Cardiac cause death		1, 12, 36, and 60 months
Other	Target vessel myocardial infarction (TV-MI)		1, 12, 36, and 60 months
Other	Clinically indicated target lesion revascularization (CI-TLR)		1, 12, 36, and 60 months
Other	Clinically indicated target vessel revascularization (CI-TVR)		1, 12, 36, and 60 months
Other	All cause death		1, 12, 36, and 60 months
Other	Any stroke		1, 12, 36, and 60 months
Other	Any MI		1, 12, 36, and 60 months
Other	Any revascularisation		1, 12, 36, and 60 months
Other	Patient-oriented composite endpoint (PoCE)	Patient-oriented composite endpoint (PoCE) is defined as all-cause death, any stroke, any MI, and any clinically indicated revascularisation	1, 12, 36, and 60 months
Other	Definite/Probable Stent thrombosis rates	According to ARC-II classification	1, 12, 36, and 60 months
Other	Peri-procedural MI	According to SCAI definition	48 hours
Other	Peri-procedural major adverse events	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	30 days
Other	Acute gain	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)	Measured by the data collected at the end of the PCI procedure
Other	The difference between post- and pre-procedural FFR/IMR	FFR/IMR can be measured either by wire or derived from coronary angiography	Measured by the data collected at the end of the PCI procedure
Other	Procedure time of the PCI		Measured by the data collected at the end of the PCI procedure
Other	Radiation dose of the PCI		Measured by the data collected at the end of the PCI procedure
Other	Contrast volume		Measured by the data collected at the end of the PCI procedure
Other	Calcium fracture		Measured by the data collected at the end of the PCI procedure
Other	Angiographic success	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).	Measured by the data collected at the end of the PCI procedure
Other	Strategy success	Strategy success is defined as Angiographic success without treatment crossover or stent loss	Measured by the data collected at the end of the PCI procedure
Other	Clinical (Procedural) success	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.	1 month
Other	Coronary flow velocity	Coronary flow velocity is measured by Quantitative Flow Ratio (QFR)	Measured by the data collected at the end of the PCI procedure
Other	TIMI Flow		Measured by the data collected at the end of the PCI procedure
Other	Stent malapposition		Measured by the data collected at the end of the PCI procedure
Other	Stent volume / reference lumen volume	Assessed by OCT	Measured by the data collected at the end of the PCI procedure
Other	Mean stent area / Mean reference lumen area	Assessed by OCT Assessed by OCT	Measured by the data collected at the end of the PCI procedure
Primary	Final stent expansion (%) assessed by OCT	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.	Measured by the data collected at the end of the PCI procedure
Primary	Target vessel failure (TVF)	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).	1, 12, 36, and 60 months
Secondary	Major cardiovascular adverse events	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.	1, 12, 36, and 60 months