AERO CAD Study Evaluating the Shockwave C2 Aero IVL System in Coronary Artery Disease

Official title

AERO CAD: A Prospective, Multi-Center, Single-Arm Study Evaluating the Shockwave C2 Aero Coronary IVL System in Calcified Coronary Artery Disease

Overview

The AERO CAD study is a prospective, multi-center, single-arm, post-market clinical investigation evaluating the procedural performance and clinical outcomes of the Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) System in patients with calcified coronary artery disease undergoing percutaneous coronary intervention (PCI). The study will enroll up to 200 subjects across up to 8 U.S. sites. The primary objective is to generate real-world evidence on device performance and clinical outcomes, including target lesion failure at 30 days and procedural success.

Detailed description

The AERO CAD study is designed to characterize real-world clinical performance and outcomes associated with the commercially available Shockwave C2 Aero Coronary IVL catheter.

Coronary artery calcification presents a major challenge during PCI, often leading to suboptimal stent expansion and adverse clinical outcomes. Intravascular lithotripsy (IVL) has emerged as a calcium modification technology that facilitates lesion preparation at low balloon pressures.

The C2 Aero IVL catheter represents a next-generation iteration with improved deliverability, lower profile, enhanced hydrophilic coating, and improved balloon durability. This study evaluates its use in routine clinical practice.

This is a prospective, single-arm, interventional post-market study enrolling patients undergoing PCI with IVL and stenting per standard of care. No additional procedures beyond standard clinical practice are required.

Subjects will be followed through discharge, 30 days, and 1 year.

Interventions

• Device Shockwave C2 Aero Coronary IVL System
  Participants undergoing PCI with coronary IVL using the Shockwave C2 Aero system followed by stent placement.

Primary outcome measures

• Target Lesion Failure (TLF) [Time frame: 30 days]
• Procedural Success [Time frame: During procedure / during hospitalization (up to 5 days)]

Secondary outcome measures (7)

• Device Success [Time frame: Index procedure]
• Serious Angiographic Complications [Time frame: Index procedure]
• IVL Device Utilization [Time frame: Index procedure]
• Target Lesion Failure (TLF) at 1 Year [Time frame: 1 year]
• Individual Components of TLF [Time frame: 30 days and 1 year]
• Stent Thrombosis [Time frame: 30 days and 1 year]
• All-Cause Mortality [Time frame: 30 days and 1 year]

Eligibility criteria

Inclusion criteria

• Age ≥18 years
• Patient undergoing percutaneous coronary intervention (PCI) for coronary artery disease
• Target lesion(s) intended for treatment with intravascular lithotripsy (IVL) and stent implantation per standard of care
• Ability to provide informed consent
• Willingness and ability to comply with study follow-up requirements

Exclusion criteria

• ST-elevation myocardial infarction (STEMI) at presentation
• Cardiogenic shock at time of procedure
• In-stent restenosis (ISR) target lesion
• Known contraindication to antiplatelet or anticoagulation therapy
• Known intolerance or contraindication to contrast media not amenable to premedication
• Participation in another investigational drug or device study that could interfere with the endpoints of this study
• Life expectancy <1 year
• Inability or unwillingness to comply with study procedures or follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 8 centers

• Los Robles Regional Medical Center — Thousand Oaks
• Henry Ford St. John Hospital — Detroit
• Jersey Shore University Medical Center — Neptune City
• The Valley Hospital — Paramus
• St Francis Hospital & Heart Center — Roslyn
• Good Samaritan University Hospital — West Islip
• WellSpan Health, York Hospital — York
• Baylor Scott & White Health - The Heart Hospital Plano — Plano

Publications

• Riley RF, Patel MP, Abbott JD, Bangalore S, Brilakis ES, Croce KJ, Doshi D, Kaul P, Kearney KE, Kerrigan JL, McEntegart M, Maehara A, Rymer JA, Sutton NR, Shah B. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions. J Soc Cardiovasc Angiogr Interv. 2024 Jan 31;3(2):101259. doi: 10.1016/j.jscai.2023.101259. eCollection 2024 Feb. PMID 39132214
• January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practic PMID 30686041
• Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinic PMID 27026020
• Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in c PMID 28886622
• Cho L, Vest AR, O'Donoghue ML, Ogunniyi MO, Sarma AA, Denby KJ, Lau ES, Poole JE, Lindley KJ, Mehran R; Cardiovascular Disease in Women Committee Leadership Council. Increasing Participation of Women in Cardiovascular Trials: JACC Council Perspectives. J Am Coll Cardiol. 2021 Aug 17;78(7):737-751. doi: 10.1016/j.jacc.2021.06.022. PMID 34384555
• Hussain Y, Kearney KE, Abbott JD, Kereiakes DJ, Di Mario C, Saito S, Cristea E, Riley RF, Fajadet J, Shlofmitz RA, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW, Lansky AJ. Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies. J Soc Cardiovasc Angiogr Interv. 2022 Jan 30;1(1):100011. doi: 10.1016/j.jscai.2021.100011. eCollection 2022 J PMID 39130137
• Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3. PMID 33939604
• Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J. 2021 May 25;85(6):826-833. doi: 10.1253/circj.CJ-20-1174. Epub 2021 Feb 5. PMID 33551398

Identifiers

NCT: NCT07512206 · OPCI-AERO-CAD-1.8-Rev D

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗