A randomized European Study Comparing Endoluminal Stent grafting and best medical Therapy (BMT) to BMT Alone in the Traetment of Acute Uncomplicated Type B Aortic Dissectio

Phase 4

• Conditions: acute uncomplicated type B aortic dissection; 10003184; 10002363

• Registration Number: NL-OMON35268
• Lead Sponsor: W.L Gore and Associates, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Presence of acute uncomplicated type B dissection
acute defined as time from symptom onset to teratment < 14 days
uncomplicated course which includes freedom from:
endorgan ischemia or evidence of malperfusion
paraplegia
rupture or impending rupture
uncontrollable pain
type b dissection where the primary entry tear is entirely distal to the left subclavian artery with only involvement of the distal aorta
aortic dissection is distinguished by radiologic evidence of an intimal flap and dual aortic lumens. Dissection variants such as intramural hematoma and penetrating ulcers are not allowed in this study.
2. maximum transverse diameter of the descending aorta < 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology
3. arterial anatomy is appropriate for stent graft therapy defined as
- proximal landing zone is not aneurysmal, dissected or significantly thrombosed
- proximal landing zone length > 2.0 cm
- proximal landing zone diameters between 23-42 mm
- non tortuous or non stenotic iliac and or femoral arteries and ability to use a conduit for vascular access.
4. able to tolerate endotracheal intubation and general anesthesia
5. age 18 to 80 years
6. declaration of voluntary participation in the study with signed informed consent form.
7. capable of complying with study protocol requirements, including long term medical treatment with beta blockers, diuretics and or ace inhibitors and follow-up for 3 years post treatment.

Exclusion Criteria

Exclusion criteria;1. ASA classification V
2. severe renal insufficiency defined as SVS risk renal status=3
3. severe respiratory insufficiency defined as SVS risk pulmonary status=3
4. presence of connective tissue disease (Marfan, Ehlers-Danlos)
5. active infection of active vasculitides
6. positive pregnancy test
7. participation in another medical research study within 3 months prior of study enrollment
8. myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
9. planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrollment
10. history of drug abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified