Endovascular Grafts for Abdominal Aortic Aneurysm

(TiGER Trial)

Recruiting at 48 trial locations

Overseen By Sammy Dhaliwal

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vascutek Ltd.

Disqualifiers: Non-compliance, Contraindications, Other studies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day 0

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and performance of Terumo Aortic endovascular grafts, which are special tubes used to repair blood vessels. The trial includes different groups, each focusing on specific conditions such as abdominal and thoracic aortic issues, and isolated iliac artery aneurysms (a bulging area in the artery wall). It seeks participants who require aortic repair with these grafts and can attend follow-up visits. Individuals advised to undergo aortic repair and who can meet the study requirements may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to the understanding and improvement of aortic repair treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Terumo Aortic endovascular grafts are generally safe. For abdominal endovascular aortic repair (EVAR), studies have found a 100% success rate in performing the procedure, with no deaths shortly after surgery. Over a follow-up period of 5.5 years, the treatment was well tolerated.

For thoracic endovascular aortic repair (TEVAR), research indicates that 93.2% of patients did not die from aneurysms. Only one instance required a change to a more invasive surgery.

For isolated iliac artery aneurysm (IIAA), the rate of major adverse events was very low, at 0.7% within 30 days after the procedure, increasing to 19.3% over four years. This suggests that the treatment is initially very safe and remains generally safe over time.

In summary, these grafts have been well-tolerated, with low rates of serious side effects or complications. These findings support the safety of the treatments under study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Terumo Aortic Endovascular Grafts because they offer a minimally invasive alternative for treating conditions like aortic aneurysms. Unlike traditional open surgery, these grafts are delivered via catheter, which can reduce recovery time and shorten hospital stays. The customizability of the devices also allows for precise tailoring to a patient's specific anatomy, potentially improving outcomes. Additionally, the option to use these grafts for various indications, such as abdominal and thoracic aneurysms, enhances their versatility and appeal in clinical settings.

What evidence suggests that this trial's treatments could be effective?

Research has shown that Terumo Aortic Endovascular Grafts effectively treat different types of aneurysms. In this trial, participants will be assigned to treatment arms based on their specific condition. For abdominal aortic aneurysms, studies found a 100% success rate in the procedure with no deaths during recovery, and results remained stable over five years. Participants in the "Abdominal - EVAR" arm will be evaluated for these outcomes. For thoracic aortic aneurysms, the RelayPro device proved safe and effective within a year, with most patients maintaining stable aneurysm sacs after five years. This will be assessed in the "Thoracic - TEVAR" arm. For isolated iliac artery aneurysms, treatment was successful in 93.1% of cases after one year, which will be examined in the "Other indications" arm. These findings highlight the grafts' potential effectiveness for various conditions. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

• Minimum age as per local regulations

Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft

Ability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Terumo Aortic endovascular stent-grafts in standard clinical practice

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Multiple visits (in-person)

Long-term follow-up

Participants' post-operative return to normal activities is recorded at one year visit

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Terumo Aortic Endovascular Grafts

How Is the Trial Designed?

Group I: Thoracic - TEVAR Experimental Treatment 1 Intervention

Group II: Other indications Experimental Treatment 1 Intervention

Isolated Iliac Artery Aneurysm (IIAA)

Group III: Custom Device Experimental Treatment 1 Intervention

Group IV: Abdominal - EVAR Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vascutek Ltd.

Lead Sponsor

Trials

18

Recruited

5,900+

Bolton Medical

Industry Sponsor

Trials

17

Recruited

2,900+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37118936/

Five-Year Outcomes of Endovascular Aortic Repair With ... In the perioperative period, we observed 100% technical success, with no perioperative mortality. Over a mean follow-up of 5.5 years (66 months) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0741521425016647

Long-term safety and effectiveness of the TREO stent graft ... The TREO pivotal study demonstrated long-term safety and effectiveness in the repair of abdominal aortic aneurysms; this next generation ...

3. terumoaortic.com terumoaortic.com/terumo-aortic-announces-publication-of-the-primary-endpoint-results-from-the-treo-pivotal-study/

Terumo Aortic announces publication of the primary ... Follow-up continues but the primary safety and effectiveness endpoint analysis is now complete and demonstrated 100% technical success, only 0.7 ...

4. terumoaortic.com terumoaortic.com/wp-content/uploads/2025/06/TREO-4-year-Annual-Report.pdf

TREO Abdominal Stent-Graft System (P190015) 4-year ... This annual clinical update provides a review of the ongoing experience with the TREO Abdominal. Stent-Graft System used in the treatment of abdominal ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(20)32491-5/fulltext

Safety and effectiveness of the TREO stent graft for ... The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment ...

6. evtoday.com evtoday.com/articles/2025-mar/clinical-study-design-for-aaa-endovascular-grafts

Clinical Study Design for AAA Endovascular Grafts The evolution of the safety and effectiveness evaluation of endovascular grafts intended for abdominal aortic aneurysm repair.