Intravascular Lithotripsy for Heart Disease

Recruiting at 12 trial locations

Overseen By Lesli DeSimone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shockwave Medical, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Heart failure, Renal disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Peri-procedural

158 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be able to tolerate antiplatelet or anticoagulation therapy as per guidelines, and if you have taken warfarin recently, your INR (a blood test) must be checked.

What data supports the effectiveness of the treatment Shockwave Intravascular Lithotripsy for heart disease?

Research shows that Shockwave Intravascular Lithotripsy is effective in treating severe calcified coronary artery conditions, helping to improve blood flow by breaking down hard calcium deposits in the arteries. It has been successfully used in complex cases where traditional methods were not effective, such as in patients with heavily calcified coronary arteries and those with multiple vessel diseases. ^{1 2 3 4 5}

How is the Shockwave Intravascular Lithotripsy treatment different from other treatments for heart disease?

Shockwave Intravascular Lithotripsy is unique because it uses acoustic shock waves to break up calcium deposits in the arteries, which helps to open up the blood vessels and improve blood flow. This method is different from other treatments that typically compress or remove tissue, as it specifically targets and fractures the calcium, making it easier to place stents and improve outcomes in patients with heavily calcified arteries. ^{1 3 6 7 8}

What is the purpose of this trial?

The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.

Research Team

Robert W Yeh, M.D., M.Sc, M.B.A

Principal Investigator

Beth Israel Deaconess Medical Center

James C Spratt, MD, MB, ChB, FRCP, FESC, FACC

Principal Investigator

St. George's University NHS Trust

Robert F Riley, MD, MS, FACC, FAHA, FSCAI

Principal Investigator

Overlake Medical Center & Clinics

Eligibility Criteria

The FORWARD CAD IDE Study is for adults over 18 with heart disease, specifically those with calcified, stenotic de novo coronary artery lesions. Participants must have a life expectancy of more than a year, be able to follow the study's procedures, and have left ventricular ejection fraction (LVEF) greater than 30%. They should not have had previous successful interventions on the lesion and must consent to participate.

Inclusion Criteria

I am willing and able to follow all study requirements.

I have heart disease that's stable or treated after a recent heart attack.

I have signed, or my legal representative has signed, the consent form to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Shockwave Javelin Coronary IVL Catheter for calcified coronary artery lesions

Peri-procedural

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on freedom from major adverse cardiac events (MACE) within 30 days

30 days

Treatment Details

Interventions

• Shockwave Intravascular Lithotripsy

Trial Overview This study tests the Shockwave Intravascular Lithotripsy (IVL) System using Javelin Coronary IVL Catheter for treating hardened blockages in heart arteries before placing stents. It's a single-arm trial meaning all participants receive the same treatment without comparison to another group or placebo.

Participant Groups

Group I: Shockwave Javelin Coronary IVL Catheter Experimental Treatment 1 Intervention

The Shockwave Javelin Coronary IVL Catheter will be used to treat subjects with moderate-to-severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) that are suitable for non-emergent percutaneous coronary intervention (PCI).

Who Is Running the Clinical Trial?

Shockwave Medical, Inc.

Lead Sponsor

Trials

38

Recruited

10,200+

References

1. England pubmed.ncbi.nlm.nih.gov

Overcoming very late severe calcific stenosis due to two layers of under-expanded stents with intravascular lithotripsy treatment: A case report. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intracoronary Lithotripsy in Calcified Coronary Lesions: A Multicenter Observational Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The Coronary Intravascular Lithotripsy System. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Intravascular Lithotripsy Facilitated Percutaneous Endovascular Intervention of the Aortic Arch: A Single-Center Experience. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of Heavily Calcified Unprotected Left Main Disease With Lithotripsy: The First Case Series. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Calcific Plaque Modification by Acoustic Shock Waves: Intravascular Lithotripsy in Coronary Interventions. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Coronary Artery Perforation After Shockwave Intravascular Lithotripsy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Use of Intravascular Lithotripsy in Heavily Calcified Renal Artery Stenosis: A Case Report. [2023]