IMPRoving Outcomes in Vascular DisEase- Aortic Dissection (IMPROVE-AD)

Duke University

Status: Enrolling

Conditions: Type B Aortic Dissection

Treatments: Procedure: TEVAR; Other: Guideline directed medical therapy and surveillance of dissection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06087029

5U24HL165029-02 (U.S. NIH Grant/Contract)

4UH3HL165017-02 (U.S. NIH Grant/Contract)

Pro00113329

Details and patient eligibility

About

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

Full description

The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 21 years
2. Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity)
3. Acuity: within 48 hours - 6 weeks of index admission
4. Ability to provide written informed consent and comply with the protocol
5. Investigator believes anatomy is suitable for TEVAR

Exclusion criteria

1. Ongoing systemic infection
2. Pregnant or planning to become pregnant in the next 3 months
3. Life expectancy related to non-aortic conditions < 2 years
4. Unwilling or unable to comply with all study procedures including serial imaging follow-up
5. Known patient history of genetic aortopathy
6. Penetrating Aortic Ulcer and Intramural hematoma
7. Iatrogenic (traumatic) aortic dissection
8. Prior surgery for aortic dissection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,100 participants in 2 patient groups

Upfront TEVAR plus Medical Therapy

Experimental group

Description:

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).

Treatment:

Other: Guideline directed medical therapy and surveillance of dissection

Procedure: TEVAR

Medical Therapy with surveillance for deterioration

Active Comparator group

Description:

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.

Treatment:

Other: Guideline directed medical therapy and surveillance of dissection