Disrupt CAD IV With the Shockwave Coronary IVL System

NCT ID: NCT04151628

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2022-03-25

Brief Summary

The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting.

Detailed Description

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention. Approximately 72 subjects at 8 sites in Japan will be enrolled. Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Conditions

Coronary Artery Disease; Myocardial Infarction

Study Design

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

Study Groups

Coronary Lithotripsy System

All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System

Group Type: EXPERIMENTAL

Lithotripsy

Intervention Type: DEVICE

Deliver Lithotripsy to the target vessel prior to placing a coronary stent

Interventions

Lithotripsy

Deliver Lithotripsy to the target vessel prior to placing a coronary stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is ≥18 years of age

2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI

3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn both must be normal)

4. For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.

1. If drawn prior to the procedure, biomarkers (troponin or CK- MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the index procedure (note: if both labs are drawn, both must be normal)

2. If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment.

5. Left ventricular ejection fraction > 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure)

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

7. Lesions in non-target vessels requiring PCI may be treated either:

1. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or

2. >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation

>normal; or

3. >30 days after the study procedure

8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure

9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:

1. Stenosis of ≥70% and <100% or

2. Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²

10. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

11. The lesion length must not exceed 40 mm

12. The target vessel must have TIMI flow 3 at baseline (visually assessed, may be assessed after pre-dilatation)

13. Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section

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

Exclusion Criteria

1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits

2. Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.

3. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint

4. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)

5. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months

6. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated

7. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's upper limit of normal

8. New York Heart Association (NYHA) class III or IV heart failure

9. Renal failure with serum creatinine >2.5 mg/dL, or chronic dialysis

10. History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit

11. Active peptic ulcer or upper gastrointestinal (GI) b≥leeding within 6 months

12. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary

13. Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)

14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders

15. Uncontrolled diabetes defined as a HbA1c ≥10%

16. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics

17. Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)

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

19. Subjects with a life expectancy of less than 1 year

20. Non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure

21. Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days after the index procedure

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

23. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy

24. Unprotected left main diameter stenosis >30%

25. Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º

26. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel

27. Evidence of aneurysm in target vessel within 10 mm of the target lesion

28. Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion

29. Target lesion is a bifurcation with ostial diameter stenosis ≥30%

30. Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches

31. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft

32. Previous stent within the target vessel implanted within the last year

33. Previous stent within 10 mm of the target lesion regardless of the timing of its implantation

34. Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

• 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

Gregg W Stone, MD

Role: STUDY_CHAIR

Columbia University

Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Shonan Kamakura General Hospital

Locations

Tenjinkai Shin-Koga Hospital

Kurume, Fukuoka, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Sakurakai Takahashi Hospital

Kobe, Hyōgo, Japan

Higashi-Takarazuka Satoh Hospital

Takarazuka, Hyōgo, Japan

Shonan-Kamakura General Hospital

Kamakura, Kanagawa, Japan

Johas Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan

Kyoto-Katsura Hospital

Kyoto, Kyoto, Japan

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 33551398 (View on PubMed)

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)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP 62611

Identifier Type: -

Identifier Source: org_study_id