Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)

NCT ID: NCT03328949

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-18
• Study Completion Date: 2019-04-25

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.

Detailed Description

The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.

Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVL Coronary Lithotripsy System

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

Group Type: EXPERIMENTAL

IVL Coronary Lithotripsy System

Intervention Type: 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).

Interventions

IVL Coronary Lithotripsy System

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is ≥ 18 years of age

2. 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

3. The target vessel must have a TIMI flow 3 at baseline

4. Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI

5. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life

6. 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

7. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography

8. Planned treatment of single lesion in one vessel

9. Ability to pass a 0.014" guide wire across the lesion

10. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures

11. Patient is able and willing to comply with all assessments in the study

Exclusion Criteria

1. Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices

2. Prior PCI procedure within the last 30 days of the index procedure

3. Patient has planned cardiovascular interventions within 30 days post index procedure

4. Second lesion with ≥50% stenosis in the same target vessel

5. Left ventricular ejection fraction < 40%

6. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery

7. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)

8. Severe renal failure with serum creatinine >2.5 mg/dL, unless on chronic dialysis

9. Untreated pre-procedural hemoglobin <10 g/dL

10. 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)

11. Patients in cardiogenic shock

12. 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

13. History of a stroke or transient ischemic attack (TIA) within 3 months

14. NYHA class III or IV heart failure

15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months

16. Patients with a life expectancy of less than 1 year

17. Target vessel < 2.4 mm in diameter

18. Target lesion > 32 mm in length

19. Chronic Total Occlusion (CTO)

20. Previous stent procedure within 5 mm of target lesion

21. Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment

22. Unprotected Left Main diameter stenosis ≥ 50%

23. Visible thrombus (by angiography) at target lesion site

24. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass

25. Patient has active systemic infection

26. Patient has connective tissue disease (e.g., Marfan's syndrome)

27. Patient has a hypercoagulable disorder

28. Uncontrolled insulin dependent diabetes

29. Patient has allergy to imaging contrast media for which they cannot be pre-medicated

30. Evidence of aneurysm in target vessel

31. Patient is pregnant or nursing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Fajadet, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic Pasteur

Carlo DiMario, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Locations

Onze-Lieve-Vrouwziekenhuis

Aalst, , Belgium

Aarhus Universitetshospital

Aarhus, , Denmark

Institut Hospitalier Jacques Cartier

Massy, , France

Clinique Pasteur

Toulouse, , France

Universitaets-Herzzentrum Freiburg- Bad Krozingen

Bad Krozingen, , Germany

Universitaetsklinikum Bonn

Bonn, , Germany

UKGM Universitaetsklinikum Giessen

Giessen, , Germany

AOU Careggi SOD Interventistica

Florence, , Italy

San Raffaelle Hospital

Milan, , Italy

Thorax Center, Erasmus MC

Rotterdam, , Netherlands

Isala Zeikenhuis- Hartecentrum

Zwolle, , Netherlands

Hospital Universitario San Carlos

Madrid, , Spain

Uppsala University Hospital

Uppsala, , Sweden

King's College Hospital

London, , United Kingdom

Oxford University Hospitals, John Radcliffe Hospital

Oxford, , United Kingdom

Countries

Belgium; Denmark; France; Germany; Italy; Netherlands; Spain; Sweden; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33939604 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31553205 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP61774

Identifier Type: -

Identifier Source: org_study_id