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Procedure

High Risk PCI Patients for Percutaneous Coronary Intervention (VITALYST EFS Trial)

N/A

Waitlist Available

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure

Awards & highlights

VITALYST EFS Trial Summary

"This trial is testing a new system called VITALYST to see if it is safe and feasible for use in patients undergoing a high-risk heart procedure called percutaneous coronary intervention."

Who is the study for?

The VITALYST EFS is for adults aged 18 to less than 90 who need a non-emergency procedure (HR-PCI) for heart vessel blockages and have reduced heart pump function. They must agree to the study's terms, be evaluated by a heart team including a surgeon, and not be in an emergency situation.Check my eligibility

What is being tested?

This trial tests the VITALYST System during elective high-risk procedures to open blocked arteries of the heart. It aims to assess how feasible and safe this system is when used in patients with serious coronary artery disease.See study design

What are the potential side effects?

While specific side effects are not listed here, interventions like HR-PCI can typically include risks such as bleeding, blood vessel damage, irregular heartbeat, or reactions related to device implantation.

VITALYST EFS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through 72 hours or hospital discharge (whichever comes first) after the intervention/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

Clinical Success

VITALYST EFS Trial Design

1Treatment groups

Experimental Treatment

Group I: High Risk PCI PatientsExperimental Treatment1 Intervention

Patients undergoing non-emergent, high-risk percutaneous coronary interventions

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor

720 Previous Clinical Trials

933,002 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 individuals aged 35 and above eligible to participate in this medical trial?

"To be considered for participation in this clinical trial, individuals must be at least 18 years old and no older than 89."

Answered by AI

Are patients currently being enrolled in this ongoing medical study?

"The study listed on clinicaltrials.gov, which was initially shared on the 1st of March 2024 and last updated on the 18th of March 2024, is not actively enrolling participants. It's worth noting that despite this particular trial not seeking candidates currently, there are a noteworthy total of 524 other trials open for patient recruitment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)

2024. "VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132568.