TCD-11226

Thoracic Stent-Graft System TCD-11226; A non-blind multicenter clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2052230047

Enrollment

Registered

2023-06-21

Start date

2023-06-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Use TCD-11226 for the thoracic aorta, brachial artery, and left common carotid artery. Note that for one case, the placement of TCD-11226 will consist of one TCD-11226 main stent graft and two TCD-112

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Contacts

Public ContactShunichiro Sugisaki

Terumo Corporation

TERUMO_CD@terumo.co.jp+81-3-6742-8500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026