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Upfront TEVAR plus Medical Therapy for Aortic Dissection (IMPROVE-AD Trial)

N/A

Recruiting

Led By Manesh R Patel, M.D.

Research Sponsored by Duke University

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 last follow-up timepoint. differential follow-up with median of about 4 years

Awards & highlights

IMPROVE-AD Trial Summary

This trial aims to see if a proactive approach combining a certain type of surgery with medication can lower the risk of death or major aortic issues compared to a more cautious approach of just using medication and monitoring

Who is the study for?

This trial is for adults over 21 with a type B aortic dissection, which is a tear in the lower part of the major artery coming from the heart. It's not for tears at or near where blood vessels branch to the head and arms. Participants must be within 6 weeks of their initial hospital visit and able to follow study procedures.Check my eligibility

What is being tested?

The trial tests if TEVAR (a minimally invasive surgery to repair the dissected aorta) combined with medical therapy works better than just medical therapy and watching patients closely for any worsening signs in treating uncomplicated type B aortic dissections.See study design

What are the potential side effects?

TEVAR can cause complications like bleeding, infection, or damage to surrounding organs. Medical therapies may include drugs that manage blood pressure but could lead to dizziness, kidney problems, or other drug-specific side effects.

IMPROVE-AD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ last follow-up timepoint. differential follow-up with median of about 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~last follow-up timepoint. differential follow-up with median of about 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and last follow-up timepoint. differential follow-up with median of about 4 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

All-cause death or major aortic complications (MAC)

Secondary outcome measures

Cumulative incidence of aortic-related hospitalizations

Cumulative incidence of cardiovascular (CV) hospitalizations

Incidence of all-cause mortality

+13 more

IMPROVE-AD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Upfront TEVAR plus Medical TherapyExperimental Treatment2 Interventions

Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment).

Group II: Medical Therapy with surveillance for deteriorationActive Control1 Intervention

Participants randomized to upfront Medical Therapy with Surveillance for Deterioration will be treated per routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

State University of New York - Downstate Medical CenterOTHER

66 Previous Clinical Trials

11,499 Total Patients Enrolled

The University of Texas Health Science Center, HoustonOTHER

904 Previous Clinical Trials

319,860 Total Patients Enrolled

3 Trials studying Aortic Dissection

5,562 Patients Enrolled for Aortic Dissection

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,419,542 Total Patients Enrolled

1 Trials studying Aortic Dissection

Frequently Asked Questions

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

Are participants being actively sought for this study at the moment?

"Indeed, data from clinicaltrials.gov indicates that this medical investigation is actively seeking suitable participants. Originally uploaded on June 30th, 2024 and most recently revised on March 20th, 2024, the trial aims to enroll approximately 1100 patients at a single research site."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Yes, information displayed on clinicaltrials.gov indicates that this study is actively seeking participants. The trial was initially published on June 30th, 2024 and most recently revised on March 20th, 2024. Recruitment aims to include 1100 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

2024. "IMPRoving Outcomes in Vascular DisEase- Aortic Dissection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087029.

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