ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy

NCT ID: NCT02622542

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 436 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2026-06-30

Brief Summary

The purpose of the study is to conduct a randomized controlled trial comparing best medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for uncomplicated acute type B aortic dissection.

Detailed Description

Study Design:

This is a prospective, two-arm, parallel-group, single-center, pragmatic, randomized clinical trial.

Population:

The target population comprises all adult patients aged 18 years and older who present with uncomplicated acute type B aortic dissection. The study sample will include 436 subjects of both genders and any race or ethnicity.

Procedures:

Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms: BMT vs BMT+TEVAR

Study Duration:

The study is expected to accrue patients over the course of 5 years and total follow up per patient for 5 years. Overall duration of the study is anticipated to be about 10 years for completion of all study endpoints.

Endpoints:

• Primary Outcome: To determine all-cause mortality among both study arms.
• Secondary Outcomes: To assess any major morbidity events (rupture, aortic intervention or reintervention, progression to complicated dissection, aneurysm formation, malperfusion resulting in organ failure, and aorta-specific mortality), as will quality of life measures, temporal discounting assessment and outcomes comparison in an observational cohort of patients who decline to be randomized due to a strong treatment preference.

Risks and Benefits:

Since this study involves only usual care and FDA-approved treatments, the investigators do not expect any additional physical risks to patients beyond those associated with usual care. One discernible risk involved in study participants is an unintentional disclosure of sensitive patient health information.

The participants of this study do not stand to benefit directly from taking part. However, the investigators hope that the results obtained from this study would provide useful information that would help delineate a standard and economical management protocol for acute Type B aortic dissection in future.

Conditions

Distal Aortic Dissection; Dissection, Aortic Acute; Acute Type B Aortic Dissection (Uncomplicated)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BMT Alone

Patients in this group will be managed with the best medical therapy (BMT) alone

Group Type: ACTIVE_COMPARATOR

BMT

Intervention Type: OTHER

Optimal medical therapy will be administered to the patients randomized to this arm, involving but not limited to, beta-blockers, etc., to control the blood pressure and pain for stabilizing the patient upon presentation.

BMT+TEVAR

Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT)

Group Type: EXPERIMENTAL

BMT+TEVAR

Intervention Type: DEVICE

These FDA-approved devices will be used for performing TEVAR in the patients randomized to this arm, in addition to the medical therapy to control blood pressure (BMT)

Interventions

BMT+TEVAR

These FDA-approved devices will be used for performing TEVAR in the patients randomized to this arm, in addition to the medical therapy to control blood pressure (BMT)

Intervention Type: DEVICE

BMT

Optimal medical therapy will be administered to the patients randomized to this arm, involving but not limited to, beta-blockers, etc., to control the blood pressure and pain for stabilizing the patient upon presentation.

Intervention Type: OTHER

Other Intervention Names

Medtronic® Valiant® Thoracic Stent Graft; Conformable GORE® TAG® Thoracic Endoprosthesis

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 years, regardless of race or ethnicity;
• Diagnosed with uncomplicated ABAD, i.e., a primary entry tear distal to left subclavian artery with no evidence of malperfusion, end-organ ischemia, rupture, or intractable pain, and onset of symptoms is ≤30 days prior to enrollment;
• Patient has been stabilized after the acute event with control of pain and blood pressure using ≤3 intravenous antihypertensive medications;
• Adequate imaging, e.g., CT with contrast (chest + abdomen+ pelvis) is available prior to enrollment; and
• Indicates willingness to comply with the study protocol and is able to provide a written informed consent;
• Meets criteria for inclusion in the National Death Index and Social Security Death Master File.

Exclusion Criteria

• Diagnosed with Type A aortic dissection;
• Evidence of complicated ABAD;
• Chronic Type B aortic dissection (>6 weeks from onset of symptoms);
• Unable to be randomized and undergo treatment according to protocol within 30 days of symptom onset;
• Diagnosed with traumatic dissection or penetrating ulcer;
• Anatomy is not suitable for TEVAR;
• Previous descending thoracic or abdominal aortic surgery (open or endovascular);
• Unsuitable access sites, including infection at access sites;
• Associated aortic aneurysm (descending aortic diameter ≥5.0 cm);
• Life expectancy <2 years;
• Unable or unlikely to comply with BMT;
• Unable or refuse to comply with follow-up;
• Intend to participate in another trial within 3 months of enrollment;
• Pregnant or breast-feeding;
• Vasculitis or known genetic connective tissue disorder (Marfan's syndrome or Ehlers-Danlos syndrome)
• Active systemic infection;
• Chronic kidney disease stage 3-5 (estimated glomerular filtration rate <60 mL/min/1.73m2);
• Cerebral vascular accident within past 3 months; or
• Clinically significant gastrointestinal bleeding, major surgery, myocardial infarction, or untreated coagulopathy within past 6 weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Harleen K Sandhu

Associate Professor, Department of Cardiothoracic and Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristofer M Charlton-Ouw, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Locations

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center

Houston, Texas, United States

Site Status: RECRUITING

Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Harleen K Sandhu, MD, MPH

Role: CONTACT

Harleen.K.Sandhu@uth.tmc.edu

7134865131

Kristofer M Charlton-Ouw, MD, FACS

Role: CONTACT

Kristofer.CharltonOuw@uth.tmc.edu

713-486-5100

Facility Contacts

Harleen K Sandhu, MD, MPH

Role: primary

harleen.k.sandhu@uth.tmc.edu

713-486-5100

Kristofer M Charlton-Ouw, MD

Role: backup

Kristofer.CharltonOuw@uth.tmc.edu

713-486-5100

Gordon Martin, MD

Role: primary

713-486-1160

Naveed Saqib, MD

Role: backup

713-486-1160

References

Afifi RO, Sandhu HK, Leake SS, Boutrous ML, Kumar V 3rd, Azizzadeh A, Charlton-Ouw KM, Saqib NU, Nguyen TC, Miller CC 3rd, Safi HJ, Estrera AL. Outcomes of Patients With Acute Type B (DeBakey III) Aortic Dissection: A 13-Year, Single-Center Experience. Circulation. 2015 Aug 25;132(8):748-54. doi: 10.1161/CIRCULATIONAHA.115.015302.

Reference Type: BACKGROUND

PMID: 26304666 (View on PubMed)

Nienaber CA, Rousseau H, Eggebrecht H, Kische S, Fattori R, Rehders TC, Kundt G, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Ince H; INSTEAD Trial. Randomized comparison of strategies for type B aortic dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation. 2009 Dec 22;120(25):2519-28. doi: 10.1161/CIRCULATIONAHA.109.886408. Epub 2009 Dec 7.

Reference Type: BACKGROUND

PMID: 19996018 (View on PubMed)

Nienaber CA, Kische S, Rousseau H, Eggebrecht H, Rehders TC, Kundt G, Glass A, Scheinert D, Czerny M, Kleinfeldt T, Zipfel B, Labrousse L, Fattori R, Ince H; INSTEAD-XL trial. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv. 2013 Aug;6(4):407-16. doi: 10.1161/CIRCINTERVENTIONS.113.000463. Epub 2013 Aug 6.

Reference Type: BACKGROUND

PMID: 23922146 (View on PubMed)

Other Identifiers

HSC-MS-15-0937

Identifier Type: OTHER

Identifier Source: secondary_id

CTVS-KC03

Identifier Type: -

Identifier Source: org_study_id