IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Type B Aortic Dissection Clinical Trial

— IMPROVE-AD  

Official title:

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087029
• Other study ID #: Pro00113329
• Secondary ID: 1UG3HL165017-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2024
• Est. completion date: June 30, 2030

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Megan Roebuck, M.S.
• Phone: 919-316-0628
• Email: megan.roebuck[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: June 30, 2030
• Est. primary completion date: June 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

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. Previous aortic dissection or aortic surgery

9. Prior aortic aneurysmal disease

Related Conditions & MeSH terms

• Aortic Dissection
• Type B Aortic Dissection
• Vascular Diseases

Intervention

Procedure:
• TEVAR
Thoracic endovascular aortic repair

Other:
• Guideline directed medical therapy and surveillance of dissection
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Locations

Country	Name	City	State
United States	University of Michigan Health	Ann Arbor	Michigan
United States	University of Colorado Denver	Aurora	Colorado
United States	Baylor Scott & White Research Institution	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Hartford Hospital	Hartford	Connecticut
United States	The University of Texas Health Houston	Houston	Texas
United States	Memorial Care Long Beach Medical Center	Long Beach	California
United States	Keck Medical Center of USC	Los Angeles	California
United States	Yale University	New Haven	Connecticut
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Honorhealth	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	St. Francis Hospital and Heart Center	Roslyn	New York
United States	University of Utah	Salt Lake City	Utah
United States	MaineHealth	Scarborough	Maine

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University, State University of New York - Downstate Medical Center, The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death or major aortic complications (MAC)	The primary endpoint is a composite of all-cause death or major aortic complications (MAC). MACs are defined as: Aortic rupture; Malperfusion,; New aortic tear requiring intervention,; Retrograde aortic dissection,; Dependence on outpatient dialysis (chronic); Major amputation (above ankle); Tracheostomy; fistula formation (e.g., aorto-esophageal, aorto-tracheal); Spinal Cord Ischemia with paralysis or paresis (power 0-2); Stroke modified Rankin Scale 2-5; AD-related intervention in either group defined as: Open TAA/TAAA Repair; Fenestrated and/or Branched Endovascular Repair of TAAA; Repeat TEVAR	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol)	An adapted version of the AAAQol survey and the Short Form 6 will be used to assess general and aortic specific quality of life. The AAAQol questionnaire was specifically developed and validated on patients with abdominal aortic aneurysms and measures both the physical and emotional impact of either 1) having an abdominal aortic aneurysm or 2) having surgical or endovascular therapy for an abdominal aortic aneurysm. This metric has been shown to be valid and responsive in abdominal aortic aneurysm. While it has not been tested in aortic dissection, its questions assess the same domains shown to be significantly impacted in patients with aortic dissection.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Cumulative incidence of cardiovascular (CV) hospitalizations	CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Mean number of cardiovascular (CV) hospitalizations	CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of cardiovascular death	Death from any cardiovascular cause.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of all-cause mortality	Death from any case	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Cumulative incidence of aortic-related hospitalizations	Aortic-related hospitalizations include hospitalizations for: aortic rupture, malperfusion, new aortic tear requiring intervention, retrograde aortic dissection, admission for BP or pain control despite adequate medical therapy, stroke, or intervention for AD, aortic interventions including open TAA/TAAA repair or fenestrated and/or branched endovascular repair of TAAA or repeat TEVAR in either group.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Mean number of aortic-related hospitalizations	Aortic-related hospitalizations include hospitalizations for: aortic rupture, malperfusion, new aortic tear requiring intervention, retrograde aortic dissection, admission for BP or pain control despite adequate medical therapy, stroke, or intervention for AD, aortic interventions including open TAA/TAAA repair or fenestrated and/or branched endovascular repair of TAAA or repeat TEVAR in either group.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of stroke	Defined as a focal neurological deficit that could be attributed to a vascular territory and lasted >24 hours or was associated with a new lesion on computed tomography scan or magnetic resonance imaging.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of paraplegia or paraparesis	Defined as including: 1) flaccid paraplegia (no lower extremity movement), or lower extremity movement without gravity, or lower extremity movement with gravity, or standing with assistance or walking with assistance (Tarlov scores 0-4).	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of vascular access injury requiring surgical repair	Defined as any open surgical procedure to treat a vascular injury at the site of vascular access for a previous endovascular procedure.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of aortobronchial / aortoesophageal fistula	Defined as fistulous connection between the aorta and bronchus as confirmed by chest imaging or direct visualization (surgical or bronchoscopic). Aortoesophageal fistula is defined as a fistulous connection between the aorta and the esophagus as confirmed by chest imaging or direct visualization (surgical or endoscopically).	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of retrograde type A dissection	Defined as any new ascending arch, or descending dissection contiguous with and proximal to the original presenting anatomy as confirmed by imaging.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of aortic-related death, including sudden cardiac deaths	Aortic-related death will be defined as death within 30 days of 1) diagnosis of aortic dissection 2) any aortic intervention or 3) ruptured aortic aneurysm. This endpoint includes sudden cardiac deaths. Sudden cardiac death will be defined as unexpected death with a preceding symptom duration of < 24 hours.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of aortic-related death, excluding sudden cardiac deaths	Aortic-related death will be defined as death within 30 days of 1) diagnosis of aortic dissection 2) any aortic intervention or 3) ruptured aortic aneurysm. This endpoint does not include sudden cardiac deaths. Sudden cardiac death will be defined as unexpected death with a preceding symptom duration of < 24 hours.	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Number of days alive and out of the hospital	Defined as the number of days alive minus the number of days in the hospital over 4 years (primary analysis).	Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary	Incidence of secondary percutaneous interventions after TEVAR	Any secondary percutaneous intervention after TEVAR	Last follow-up timepoint. Differential follow-up with median of about 4 years