Endovascular Treatment of Thoracic Aortic Disease — EVOLVE Aorta  

Aortic Dissection Clinical Trial

Official title: Endovascular Treatment of Thoracic Aortic Disease

Status Enrolling by invitation

Clinical Trial Summary

The purpose of this study is to assess the role endovascular therapy to treat aortic disease involving the ascending aorta, the aortic arch, and the visceral segment of the aorta (or thoracoabdominal aorta)

Clinical Trial Description

This study is a prospective, non-randomized, single-site evaluation of the use of novel endovascular technology to treat complex aortic disease.

In an effort to allow for the evaluation of patients with both complex anatomic condition and challenging physiologic situations there are three study subsections as follows:

1. Ascending Arm Protocol: The intended use of the study is to provide endovascular therapy to patients with ascending aortic pathology including aneurysm, pseudoaneurysm, and/or aortic dissection who are considered high risk for conventional surgery. This will involve disease in the aorta from the sinotubular junction to the innominate artery.

2. Aortic Arch Arm Protocol: The intended use of the study is to provide endovascular therapy to patients with aortic arch pathology including aneurysm, pseudoaneurysm and/or aortic dissection who are considered high risk for conventional surgery. This will involve disease in aorta from the sinotubular junction to descending thoracic aorta.

3. Thoracobabdominal Aortic Arm Protocol: The intended use of the study is to provide endovascular therapy to patients with thoracoabdominal aortic pathology including aortic aneurysms, renal aneurysms, and superior mesenteric artery aneurysms. This will involve the aorta from the left carotid artery origin through the iliac artery bifurcation.

In addition, the purpose of the study is also characterized based on the protocol arm that patients are enrolled:

1. Ascending Arm Protocol: The purpose of this study is to assess the safety, efficacy, and intermediate (or long-term) rupture free survival rate of high risk surgical patients undergoing endovascular repair of ASCENDING AORTIC pathology including aortic dissection, aortic aneurysm, and/or aortic pseudoaneurysm. The objectives of this arm are as follows:

• To assess the safety, efficacy and intermediate (or long-term) durability of an endovascular prosthesis as a means of preventing ascending aortic growth and rupture in high risk patients.

• To measure the physiologic effects and outcomes of endovascular aneurysm repair.

• Establish selection criteria, improve device design, operative technique and follow-up procedures for patients undergoing endovascular aneurysm repair.

2. Arch Arm Protocol: The purpose of this study is to assess the safety, efficacy, and intermediate (or long-term) rupture free survival rate of high risk surgical patients undergoing endovascular repair of AORTIC ARCH pathology including aortic aneurysm, pseudoaneurysm and/or dissection. The objectives of this arm are as follows:

• To assess the safety, efficacy and intermediate (or long-term) durability of an endovascular prosthesis as a means of preventing aortic arch growth and rupture in high risk patients.

• To measure the physiologic effects and outcomes of endovascular aneurysm repair.

• Establish selection criteria, improve device design, operative technique and follow-up procedures for patients undergoing endovascular aneurysm repair.

3. Thoracoabdominal Arm Protocol: The purpose of this study is to assess the long-term safety, durability and rupture free survival of surgical patients undergoing endovascular repair of the THORACOABDOMINAL AORTA involving pathologies that include thoracoabdominal aortic aneurysms, renal artery aneurysms and superior mesenteric artery aneurysms.

• To assess the long-term safety and durability of an endovascular prosthesis as a means of preventing aneurysm growth and rupture in patients having aneurysms involving the THORACOABDOMINAL AORTA.

• To measure the physiologic effects and outcomes of endovascular aneurysm repair.

• Establish selection criteria, improve device design, operative technique and follow-up procedures for patients undergoing endovascular aneurysm repair involving the THORACOABDOMINAL AORTA. ;

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Arch; Aneurysm, Dissecting
• Aortic Diseases
• Aortic Dissection
• Ascending Aorta Aneurysm
• Ascending Aortic Dissection
• Dissecting, Aneurysm
• Renal Artery Aneurysm
• Superior Mesenteric Artery Aneurysm
• Thoracic Aortic Aneurysms
• Thoracoabdominal Aortic Aneurysm

• NCT number: NCT00583817
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 25, 2018
• Completion date: December 2027