An observational study in Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture, Abdominal Aortic Aneurysm Without Rupture and Thoracic Aortic Aneurysm Without Rupture, sponsored by Rede Optimus Hospitalar SA. Recruiting at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Rede Optimus Hospitalar SA · Observational
Among 10 studies in Aortic Aneurysm, Thoracoabdominal with a site in Germany — 3 open to participants now, 6 under way, none of them phase 3. Aortic Aneurysm, Thoracoabdominal · Germany.
Among the 10 studies in Aortic Aneurysm, Thoracoabdominal with a site in Germany, this one is one of 3 that started in 2025, is one of 5 observational ones, and was the 8th registered.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
Browse Aortic Aneurysm, Thoracoabdominal studies →3 of the 10 studies in Aortic Aneurysm, Thoracoabdominal with a site in Germany are open now. Recruiting first, the newest first:
Lifetech Scientific (Shenzhen) Co., Ltd. · Sites in Germany
Cook Research Incorporated · Sites in Germany, Denmark, France and 3 more countries
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 25 Aortic Aneurysm, Thoracoabdominal studies recruiting now, 18 (72%) set no upper age limit and 0 (0%) stop at 75 or younger; 2 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 30 is below the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Median enrollment 103 across the 5 interventional studies, 100 across the 5 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 10 have an industry lead sponsor. The 9 most frequent:
Rede Optimus Hospitalar SA is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Rede Optimus Hospitalar SA has 1 study filed under Aortic Aneurysm, Thoracoabdominal — fewer than ten, so there is no comparison to draw.
1 of the studies in Aortic Aneurysm, Thoracoabdominal with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05896397Cook Research IncorporatedEuropean Aortic Data Collection Project | 2027-01 |
Among the 10 studies in Aortic Aneurysm, Thoracoabdominal with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.
The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.
Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure.
In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.
Patient (m/f) age ≥ 18 years
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Hostile iliac access was defined in the presence of:
We will accept the following presentations of aneurysm:
Exclusion Criteria:
Patients submitted to complex endovascular thoracic aortic repair with hostile iliac access vessels using the Shockwave device to gain access.
Device: Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+
Cracking-not-debulking technique (SHOCKWAVE IVL)
Efficacy: Technical success - defined as intention-to-treat basis
* Successful dilatation of the access vessels to 8mm without rupture * Successful endovascular access and deployment of all aortic devices * Performance of the Shockwave™ IVL: Includes the definition for technical success as well as delivery of the intended main endograft without the need for surgical conversion, arterial rupture and iliac artery occlusion
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for May 2026, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
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Aortic Aneurysm, Thoracoabdominal →
Rede Optimus Hospitalar SA