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Procedure

Shortcut for Coronary Artery Disease (ShortCut CAS Trial)

N/A

Waitlist Available

Research Sponsored by Pi-cardia

Eligibility Criteria Checklist

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

Must have

Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post procedure

Awards & highlights

ShortCut CAS Trial Summary

This trial is being conducted to gather more information about the safety and effectiveness of the ShortCut™ device. This device is used to split bioprosthetic aortic valve leaflets and ensure that the

Who is the study for?

This trial is for patients needing aortic valve replacement who are at risk of coronary artery blockage from a valve-in-valve (ViV) procedure. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Check my eligibility

What is being tested?

The ShortCut™ device is being tested in this non-randomized, single-arm study. It's designed to split bioprosthetic aortic valve leaflets to prevent blockage of coronary arteries during ViV procedures in patients requiring aortic valve replacement.See study design

What are the potential side effects?

While specific side effects are not listed, generally such interventions may include risks like bleeding, infection, damage to nearby heart structures, irregular heartbeats or other complications related to heart procedures.

ShortCut CAS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for a valve-in-valve procedure due to a failed heart valve replacement.

ShortCut CAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intra-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intra-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-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

Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography

ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke

Secondary outcome measures

-Rate of major vascular complications per VARC-3

Access-related type 3-4 bleeding per VARC-3

Rate of Acute Kidney Injury per VARC-3

+7 more

Other outcome measures

Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3

Rate of all cause mortality per VARC-3

Rate of stroke per VARC-3

ShortCut CAS Trial Design

1Treatment groups

Experimental Treatment

Group I: ShortcutExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pi-cardiaLead Sponsor

4 Previous Clinical Trials

175 Total Patients Enrolled

Frequently Asked Questions

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

Are there still available slots for patients to participate in this ongoing clinical trial?

"According to the information provided on clinicaltrials.gov, this specific study is no longer actively seeking participants. It was initially posted on April 1st, 2024, and last updated on January 8th, 2024. However, it's worth noting that there are currently other studies available for potential participants to consider with one accepting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The ShortCut™ Continued Access Study Protocol

2024. "The ShortCut™ Continued Access Study Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06211296.

All > Aortic Stenosis