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Procedure

Single-Arm for Coronary Artery Disease

Q: Is there still capacity to enroll new participants in this research?

<p>According to the most recent information on clinicaltrials.gov, this particular medical trial has closed recruitment and is no longer looking for participants. The initial posting date was December 1st 2023 while the last update occurred on December 4th 2023. Nevertheless, there are still 822 other studies that are actively searching for volunteers at present time.</p>

Q: What objectives are researchers aiming to achieve through this clinical trial?

<p>The main objective of this clinical trial, as reported by Shockwave Medical Inc., is the number of patients that have procudural success with a residual stenosis less than 30% over 30 days. Secondary measurements include ID-TLR rate at 6 months (KM estimated event rates), stent thrombosis rate at 30 days (proportions) and cardiac death rate at 30 day (proportions).</p>

N/A

Recruiting

Research Sponsored by Shockwave Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is ≥18 years of age

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of index procedure

Awards & highlights

Study Summary

This trial tests a device to clear plaque from blocked coronary arteries to improve blood flow before stenting.

Who is the study for?

This trial is for adults over 18 with coronary artery disease, including those with stable or unstable angina and silent ischemia suitable for PCI. Participants must have normal levels of certain heart enzymes before the procedure and a left ventricular ejection fraction greater than 25%. They must consent to participate.Check my eligibility

What is being tested?

The study tests the Shockwave C2+ 2Hz Coronary IVL Catheter's safety and effectiveness in treating calcified, narrowed arteries in the heart before stenting. It uses shockwaves to modify arterial calcium.See study design

What are the potential side effects?

Potential side effects may include discomfort at the catheter insertion site, bleeding, blood vessel complications, irregular heartbeats, or reactions related to pressure changes from shockwaves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have heart disease that can be treated with a procedure to open my arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of index procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure

Number of Participants With Procedural Success (Residual Stenosis <30%)

Secondary outcome measures

All-Cause Death Rate at 12 Months

All-Cause Death Rate at 30 Days

All-Cause Death Rate at 6 Months

+46 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-ArmExperimental Treatment1 Intervention

Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shockwave Medical, Inc.Lead Sponsor

28 Previous Clinical Trials

8,021 Total Patients Enrolled

8 Trials studying Coronary Artery Disease

2,445 Patients Enrolled for Coronary Artery Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still capacity to enroll new participants in this research?

"According to the most recent information on clinicaltrials.gov, this particular medical trial has closed recruitment and is no longer looking for participants. The initial posting date was December 1st 2023 while the last update occurred on December 4th 2023. Nevertheless, there are still 822 other studies that are actively searching for volunteers at present time."

Answered by AI

What objectives are researchers aiming to achieve through this clinical trial?

"The main objective of this clinical trial, as reported by Shockwave Medical Inc., is the number of patients that have procudural success with a residual stenosis less than 30% over 30 days. Secondary measurements include ID-TLR rate at 6 months (KM estimated event rates), stent thrombosis rate at 30 days (proportions) and cardiac death rate at 30 day (proportions)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

2023. "Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05966662.

All > Coronary Artery Disease