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CompletedNCT02650128Updated Nov 2, 2018Results posted

Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)

An interventional study of Shockwave Coronary Rx Lithoplasty® System in Coronary Artery Disease, sponsored by Shockwave Medical, Inc.. Completed at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by Shockwave Medical, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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 enrolled and consented in the study based on history and in some instances an angiogram obtained prior to the study. The study is designed to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, coronary arteries. Subjects will be prepared for PCI per the institution's standard protocol. Medications will be administered per the treatment protocol. Femoral access will be obtained using a 6F access sheath, and guiding catheter placed at the ostia of the right or left coronary artery. Baseline angiography of the culprit lesion will be performed prior to placement of a 0.014" guide wire. Baseline and either IVUS or OCT will be performed to determine the Maximum Lumen Area (MLA), percent stenosis, and volumetric lesion assessment. Baseline angiography will be performed to determine lesion length, % stenosis and reference vessel diameter. The investigational device will be prepped per the IFU and positioned at the target lesion. The distal end of the balloon catheter will be connected to the patient cable. The balloon catheter will be inflated to 4 atm and the investigator will deliver 10 pulses for 20 seconds. The balloon will then be inflated to reference vessel diameter and then deflated to reestablish flow and complete one treatment cycle. The treatment cycle will then be repeated. Angiography and either IVUS or OCT will be repeated for the treated lesion.. A coronary stent will be deployed at the site of treatment. Angiography and either IVUS or OCT will be performed following stent placement. Patients will be followed through discharge and at 30 and 180 days. A subset of up to five (5) subjects will receive an angiographic assessment at the 180 day follow up visit, per the Sponsor's discretion.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary Artery Disease
  • Calcified Coronary Lesions
  • Coronary Arterial Stenosis
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shockwave Medical, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 12 hours prior to the procedure
  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 lesions 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

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
  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 elevated Troponin-I or T (with concomitant elevation of CPK) at the time of enrollment.
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Lithoplasty System

    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

  • DeviceShockwave Coronary Rx Lithoplasty® System

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

  2. 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.

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

Secondary outcomes

  1. Quantitative Assessment of the Residual Stenosis in Treated Lesions

    Angiographic success defined as success in facilitating stent deliver with \<50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow

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

  2. 180 Day MACE

    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

    Time frame: 180 days post-procedure

07

Results

Posted Nov 2, 2018

Participant flow

Study recruitment and enrollment took place at seven clinical sites in Australia and Europe between December 2015 and September 2016. A total of 60 subjects with calcified, stenotic de novo coronary arteries were enrolled and treated with the investigational device.

Participant flow — Overall Study
MilestoneShockwave Coronary Rx Lithoplasty System
Started60
30 day primary and safety endpoint60
Completed58
Not completed2
Withdrew: Death2

Outcome measures

PrimarySafety - 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

Time frame:
30 days
Reported as:
Number · events
Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.
eventsShockwave Coronary Rx Lithoplasty System
Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.57
PrimaryPerformance

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.

Time frame:
Post-procedure (within 24 hours following procedure and prior to discharge)
Reported as:
Count of participants · Participants
Performance
ParticipantsShockwave Coronary Rx Lithoplasty System
Performance57
SecondaryQuantitative Assessment of the Residual Stenosis in Treated Lesions

Angiographic success defined as success in facilitating stent deliver with \<50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow

Time frame:
Post-procedure (within 24 hours following procedure and prior to discharge)
Reported as:
Count of participants · Participants
Quantitative Assessment of the Residual Stenosis in Treated Lesions
ParticipantsShockwave Coronary Rx Lithoplasty System
Quantitative Assessment of the Residual Stenosis in Treated Lesions58
Secondary180 Day MACE

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

Time frame:
180 days post-procedure
Reported as:
Number · events
180 Day MACE
eventsLithoplasty System
180 Day MACE58

Adverse events

Collected over through 30 days and 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Shockwave Coronary Rx Lithoplasty System2/60 (3.3%)10/60 (16.7%)37/60 (61.7%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventShockwave Coronary Rx Lithoplasty System
Coronary Artery DissectionCardiac disorders3/60
AnaemiaBlood and lymphatic system disorders1/60
Angina UnstableCardiac disorders1/60
Sinus BradycardiaCardiac disorders1/60
Upper Gastrointestinal HaemorrhageGastrointestinal disorders1/60
CellulitisInfections and infestations1/60
SepsisInfections and infestations1/60
Urinary Tract InfectionInfections and infestations1/60
Cerebral HypoperfusionNervous system disorders1/60
Renal Failure AcuteRenal and urinary disorders1/60
Most frequent other events
Showing 10 of 37
Most frequent other events
EventShockwave Coronary Rx Lithoplasty System
Coronary Artery DissectionCardiac disorders12/60
Enzyme Level IncreasedInvestigations7/60
Chest PainGeneral disorders5/60
Troponin IncreasedInvestigations3/60
HeadacheNervous system disorders3/60
DyspnoeaRespiratory, thoracic and mediastinal disorders3/60
Chest DiscomfortGeneral disorders2/60
Puncture Site PainGeneral disorders2/60
Post Procedural HaematomaInjury, poisoning and procedural complications2/60
Groin PainMusculoskeletal and connective tissue disorders2/60

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Shockwave Coronary Rx Lithoplasty System
<=18 years0
Between 18 and 65 years13
>=65 years47
Sex: Female, Male
Sex: Female, Male(Participants)Shockwave Coronary Rx Lithoplasty System
Female12
Male48
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Shockwave Coronary Rx Lithoplasty System
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American1
White47
More than one race0
Unknown or Not Reported10
Region of Enrollment
Region of Enrollment(Participants)Shockwave Coronary Rx Lithoplasty System
Netherlands4
Sweden1
United Kingdom29
Australia16
France10
08

Study locations

7 sites
  • Monash Heart, Monash Health
    Clayton, Victoria VIC 3168, Australia
  • St. Vincent's Hospital
    Melbourne, Victoria VIC 3065, Australia
  • Clinic Pastuer
    Toulouse, BP 27617, France
  • Thoraxcenter, Erasmus MC
    Rotterdam, 3000 CA, Netherlands
  • Skane University Hospital- Lund
    Lund, 22185, Sweden
  • King's College Hospital
    London, SE5 9RS, United Kingdom
  • Royal Brompton Hospital
    London, SW3 6NP, United Kingdom
09

References and documents

Publications

  • 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. PubMed 33939604 ↗
  • 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. PubMed 30715944 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02650128
Lead sponsor
Shockwave Medical, Inc.
Responsible party
Sponsor
First posted
Jan 8, 2016
Start date
Dec 2015
Primary completion
Sep 2016
Completion
Mar 2017
Results posted
Nov 2, 2018
Last update
Nov 2, 2018

Study contacts

Jean Fajadet, MD
principal investigator · Clinic Pastuer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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