TCD-11226

Phase 3

Suspended

• Conditions: Residual aortic dissection (including pseudoaneurysm at the anastomotic site) after ascending aortic

• Registration Number: JPRN-jRCT2052230047
• Lead Sponsor: Sugisaki Shunichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Age is >= 18 years at the time of informed consent.
2. Patients considered suitable for TEVAR using thoracic stent-graft system TCD-11226 after comprehensive evaluation of risk factors and consideration of other treatment options.
3. Patients with a minimum inner diameter of the central landing zone of the TCD-11226 main stent-graft of 28 mm or larger.
4. Patients with no dissection in BCT and LCCA, which are landing zones of the TCD-11226 branch stent-graft.
5. Patients with femoral/iliac artery diameter accessible with 25 Fr delivery catheter.

Exclusion Criteria

1. Patients with inaccessible access from the femoral or iliac artery.
2. Patients with difficult-to-pass stenosis or Grade 2 or higher atherosclerotic thrombosis in the TCD-11226 branch stent-graft device approach vessel.
3. Patients with Grade 2 or higher atherosclerotic thrombosis at the landing zone of the TCD-11226 branch stent-graft.
4. Patients who have had symptomatic stroke or cerebral hemorrhage within 6 months prior to trial registration.
5. Patients who have participated in another clinical trial of a pharmaceutical product or medical device within 1 year prior to trial registration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Primary endpoint<br>(1) Effectiveness endpoint<br>Percentage of subjects achieving all of the following four items up to 1 year after treatment:<br>1 No occurrence of stent-graft migration (>=10 mm)<br>2 No occurrence of complete occlusion of branch stent-grafts<br>3 No secondary therapeutic intervention for Type I or Type III endoleaks<br>4 No occurrence of death due to aortic rupture at the treatment site<br><br>(2) Safety endpoint<br>Percentage of subjects with any of the following six events within 30 days after treatment (6 judged on the day of treatment):<br>1 All-cause mortality<br>2 Stroke<br>3 Paraplegia/Paraparesis<br>4 New post-treatment dialysis<br>5 Aortic rupture at the treatment site<br>6 Unsuccessful device placement