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

NCT02622542 | Recruiting DMC FDA Device

• 2 other identifiers: CTVS-KC03HSC-MS-15-0937
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Participants would be followed for a period of 5 years following initial presentation

  5 years

Secondary Outcomes (2)

• Any major morbidity events

  5 years

• Change in Quality of Life assessment

  5 years

Study Arms (2)

BMT Alone

ACTIVE COMPARATOR

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

Other: BMT

BMT+TEVAR

EXPERIMENTAL

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

Device: BMT+TEVAR

Interventions

BMT+TEVAR 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)

Also known as: Medtronic® Valiant® Thoracic Stent Graft, Conformable GORE® TAG® Thoracic Endoprosthesis

BMT+TEVAR

BMT 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 Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

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

Houston, Texas, 77030, United States

RECRUITING

Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast

Houston, Texas, 77089, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 26304666 BACKGROUND

• 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.

  PMID: 19996018 BACKGROUND

• 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.

  PMID: 23922146 BACKGROUND

Study Officials

• Kristofer M Charlton-Ouw, MD, FACS

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harleen K Sandhu, MD, MPH

CONTACT

7134865131; Harleen.K.Sandhu@uth.tmc.edu

Kristofer M Charlton-Ouw, MD, FACS

CONTACT

713-486-5100; Kristofer.CharltonOuw@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant and investigator/treating physician would be blinded until the day of treament initiation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Cardiothoracic and Vascular Surgery

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: October 1, 2018
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)