Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

NCT03328949 | Completed Results

• 1 other identifier: CP61774
• Study Type: interventional
• Target: 120
• Locations: 9 countries
• Sites: 15

Brief Summary

The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)

  The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following: * Cardiac death * Myocardial Infarction - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

  Post-procedure through hospital discharge

Secondary Outcomes (3)

• Number of Participants With Clinical Success

  During procedure through hospital discharge

• Number of Participants With Angiographic Success

  During procedure

• Number of Participants Which Experienced Cardiac Death

  30 days post-procedure

Study Arms (1)

IVL Coronary Lithotripsy System

EXPERIMENTAL

All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement.

Device: IVL Coronary Lithotripsy System

Interventions

IVL Coronary Lithotripsy System DEVICE

The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).

IVL Coronary Lithotripsy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age
• Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal
• The target vessel must have a TIMI flow 3 at baseline
• Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
• Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life
• Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length
• Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
• Planned treatment of single lesion in one vessel
• Ability to pass a 0.014" guide wire across the lesion
• Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
• Patient is able and willing to comply with all assessments in the study

You may not qualify if:

• Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
• Prior PCI procedure within the last 30 days of the index procedure
• Patient has planned cardiovascular interventions within 30 days post index procedure
• Second lesion with ≥50% stenosis in the same target vessel
• Left ventricular ejection fraction \< 40%
• Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
• Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
• Severe renal failure with serum creatinine \>2.5 mg/dL, unless on chronic dialysis
• Untreated pre-procedural hemoglobin \<10 g/dL
• Coagulopathy manifested by platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
• Patients in cardiogenic shock
• Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain
• History of a stroke or transient ischemic attack (TIA) within 3 months
• NYHA class III or IV heart failure
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (15)

Onze-Lieve-Vrouwziekenhuis

Aalst, Belgium

Location

Aarhus Universitetshospital

Aarhus, Denmark

Location

Institut Hospitalier Jacques Cartier

Massy, France

Location

Clinique Pasteur

Toulouse, France

Location

Universitaets-Herzzentrum Freiburg- Bad Krozingen

Bad Krozingen, Germany

Location

Universitaetsklinikum Bonn

Bonn, Germany

Location

UKGM Universitaetsklinikum Giessen

Giessen, Germany

Location

AOU Careggi SOD Interventistica

Florence, Italy

Location

San Raffaelle Hospital

Milan, Italy

Location

Thorax Center, Erasmus MC

Rotterdam, Netherlands

Location

Isala Zeikenhuis- Hartecentrum

Zwolle, Netherlands

Location

Hospital Universitario San Carlos

Madrid, Spain

Location

Uppsala University Hospital

Uppsala, Sweden

Location

King's College Hospital

London, United Kingdom

Location

Oxford University Hospitals, John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (2)

• 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 DERIVED

• Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.

  PMID: 31553205 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Beaux Alexander, Vice President of Clinical Affairs
• Organization: Shockwave Medical, Inc.

balexander@shockwavemedical.com

510-279-4262 ext. 145

Study Officials

• Jean Fajadet, MD

  Clinic Pasteur

  PRINCIPAL INVESTIGATOR

• Carlo DiMario, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intravascular Coronary Lithotripsy System

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 1, 2017
• Study Start: May 18, 2018
• Primary Completion: March 26, 2019
• Study Completion: April 25, 2019
• Last Updated: November 19, 2019
• Results First Posted: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DK (1); IT (2); DE (3); GB (2); BE (1); SE (1); FR (2); NL (2)