Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

NCT02650128 | Completed Results

• 1 other identifier: TD 0257
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 7

Brief Summary

Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Calcified Coronary Lesions; Coronary Arterial Stenosis

Outcome Measures

Primary Outcomes (2)

• Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.

  MACE defined as: * 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 the target lesion) after the completion of the index procedure

  30 days

• Performance

  The ability of the Shockwave System to produce acceptable residual stenosis (\<50%) after stenting with no evidence of in-hospital MACE. Clinical success measured by each patient that achieves both these requirements.

  Post-procedure (within 24 hours following procedure and prior to discharge)

Secondary Outcomes (2)

• Quantitative Assessment of the Residual Stenosis in Treated Lesions

  Post-procedure (within 24 hours following procedure and prior to discharge)

• 180 Day MACE

  180 days post-procedure

Study Arms (1)

Lithoplasty System

EXPERIMENTAL

Shockwave Coronary Rx Lithoplasty® System is a lithotripsy-enhanced, low-pressure balloon dilation of calcified, stenotic de novo coronary arteries prior to stent placement

Device: Shockwave Coronary Rx Lithoplasty® System

Interventions

Shockwave Coronary Rx Lithoplasty® System DEVICE

The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.

Also known as: Coronary Rx Lithoplasty System

Lithoplasty 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 12 hours prior to the procedure
• 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 lesions 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
• 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 elevated Troponin-I or T (with concomitant elevation of CPK) at the time of enrollment.
• 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 (7)

Monash Heart, Monash Health

Clayton, Victoria, VIC 3168, Australia

Location

St. Vincent's Hospital

Melbourne, Victoria, VIC 3065, Australia

Location

Clinic Pastuer

Toulouse, BP 27617, France

Location

Thoraxcenter, Erasmus MC

Rotterdam, 3000 CA, Netherlands

Location

Skane University Hospital- Lund

Lund, 22185, Sweden

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, 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

• Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. No abstract available.

  PMID: 30715944 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 Clinical Affairs
• Organization: Shockwave Medical, Inc.

balexander@shockwavemedical.com

510-279-4262

Study Officials

• Jean Fajadet, MD

  Clinic Pastuer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 8, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-03

Locations

NL (1); GB (2); FR (1); AU (2); SE (1)