Terumo Aortic Grafts for Aortic Disease

(PANTHER Trial)

Recruiting at 30 trial locations

Overseen By Clinical Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vascutek Ltd.

Disqualifiers: Non-compliance, Contraindications, others

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

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial collects information on the safety and performance of Terumo Aortic's knitted and woven grafts, as well as cardiovascular patches. Surgeons use these medical devices to repair or replace blood vessels, which is crucial for conditions like aneurysms (a bulge in a blood vessel) or blocked arteries. The trial examines different types of these grafts and patches in various heart and blood vessel surgeries. Individuals who have had or need these types of surgeries in the last five years might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the availability of these potentially life-saving 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.

What is the safety track record for these treatments?

Research has shown that Terumo Aortic's knitted and woven grafts and cardiovascular patches are generally well-tolerated. Studies indicate that the Gelweave Valsalva Vascular Graft provides good long-term results with a low likelihood of requiring additional surgery. In one study covering 491 patient years, no early deaths were reported.

The Gelsoft Plus Vascular Graft has undergone clinical testing and received FDA approval for treating aneurysms and blocked vessels, suggesting its safety. However, a recall affected certain batches, so only approved versions should be used.

Studies have demonstrated safe outcomes for the Gelsoft Plus Extra-Anatomical Vascular Graft in surgeries like axillo-femoral bypass.

The Gelweave Vascular Graft is also trusted in medical use, with tests confirming its safety for addressing serious artery issues like aortic aneurysms.

Finally, studies have shown that cardiovascular patches used in surgeries, such as repairing carotid arteries, carry low risks. These patches are a safe option for many heart and blood vessel repairs.

In summary, research supports the safety and effectiveness of these treatments for many patients. It's always important to discuss any concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the innovations involved in Terumo Aortic's knitted and woven grafts and cardiovascular patches because they offer potential advancements over traditional synthetic grafts and patches used for vascular repairs. Unlike standard treatments, which often rely on less flexible materials, these new grafts and patches are designed to mimic the natural elasticity of blood vessels, potentially reducing complications like leaks or blockages. Additionally, the Gelweave and Gelsoft grafts are tailored for various anatomical needs, from aortic root repairs to peripheral bypasses, providing a more customized approach for patients with complex vascular conditions. This adaptability and the potential for better integration with the body's tissues could lead to improved outcomes and fewer post-surgery complications.

What evidence suggests that these cardiovascular patches and vascular grafts are effective for vascular repair?

Research has shown that the Gelweave Valsalva Vascular Graft, one of the treatments in this trial, performs well in surgeries involving aortic root replacement. Studies indicate it provides excellent short- and mid-term results, with high survival rates and a low likelihood of requiring additional surgeries. Another treatment option in this trial, the Gelsoft Plus Vascular Graft, made from a special type of polyester and sealed with gelatin, swells less than other grafts, making it a reliable choice for treating artery problems. The Gelweave Vascular Graft, also included in this trial, proves effective in complex surgeries involving the aorta, aiding in efficient reconstruction. Lastly, Cardiovascular Patches, used to repair blood vessels, have demonstrated good long-term results in maintaining open arteries and reducing the risk of future blockages. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient meets the minimum age as per local regulations at time of consent

Patient requires treatment with study device(s) according to the IFU(s)

Patient is willing and able to comply with all SOC procedures and study visits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Data is collected retrospectively and prospectively on the use of Terumo Aortic knitted and woven grafts, and cardiovascular patches

1 year

Follow-up

Participants are monitored for safety and performance outcomes, including procedural and device endpoints

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cardiovascular Patch
• Gelsoft Plus Vascular Graft
• Gelweave Valsalva Vascular Graft
• Gelweave Vascular Graft
• Vascular Bypass Graft

How Is the Trial Designed?

Group I: Gelweave - Valsalva Experimental Treatment 1 Intervention

Patients who have had/require aortic root repair using valve sparing or valve replacing procedures, with or without replacement of the aortic arch, implanted in the last 5 years and from study launch onwards.

Group II: Gelweave - Abdominal, Thoracic, Thoracoabdominal Experimental Treatment 1 Intervention

Patients who, due to either aneurysmal or occlusive disease, have had/require vascular repair of one of the following, implanted in the last 5 years and from study launch onwards: * Abdominal aorta, arteries arising from the abdominal aorta or peripheral arteries including femoral, iliac and popliteal arteries. * Thoracic aorta or arteries arising from the thoracic aorta. * Abdominal and thoracic aorta requiring a thoracoabdominal repair

Group III: Gelsoft Plus - Straights and Bifurcated Experimental Treatment 1 Intervention

Patients with aneurysmal or occlusive disease, including those with connective tissue disorders who have received/will receive a Gelsoft Plus Straight or Bifurcate, implanted in the abdomen or peripheral arteries in the last 5 years and from study launch onwards.

Group IV: Gelsoft Plus - Extra-Anatomical Experimental Treatment 1 Intervention

Any patients who have received/will receive a Gelsoft Plus Extra-Anatomical supported or unsupported graft, implanted for: axillary-femoral bypass, femoral-femoral bypass or femoral-popliteal bypass in the last 5 years and from study launch onwards.

Group V: Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall Experimental Treatment 1 Intervention

Patients who have been implanted with/require a cardiovascular patch for: thoracic vessel repair with a Gelseal Cardiovascular Patch; abdominal or peripheral vessel repair with a Gelsoft Cardiovascular Patch; or carotid endarterectomy with a Thin Wall Carotid Patch in the last 5 years and from study launch onwards.

Who Is Running the Clinical Trial?

Vascutek Ltd.

Lead Sponsor

Trials

18

Recruited

5,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12188973/

and long-term outcomes following carotid endarterectomy ... This study aims to evaluate the mid- and long-term outcomes of patients who underwent carotid endarterectomy with double-layer primary arteriotomy closure ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468428724002466

Outcome of primary closure following carotid ... This study evaluated the safety and efficacy of a novel primary closure technique in carotid endarterectomy compared with traditional methods.

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/15385744251360825

Ten-Year Experience With Primary Repair and Selective ... The secondary outcomes were >30-day ipsilateral ischemic stroke, reintervention and primary patency. All outcomes were analyzed in relation to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33644135/

Extracellular Matrix Patches for Endarterectomy Repair Here we review the use of decellularized extracellular matrix (ECM) for cardiovascular applications, particularly endarterectomy repair.

5. esmed.org esmed.org/MRA/mra/article/download/4601/99193547351/

Complication Rate After Carotid Endarterectomy ... Results: Primary closure was used in 110 operations, and patch angioplasty in 103 procedures (Dacron patch). Primary closure was performed when ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6116460/

Risk and Outcome after Simultaneous Carotid Surgery ... Simultaneous carotid artery surgery and open-heart surgery have low risk. The underlying cardiac disease influences outcome.

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/15385744251360825

Ten-Year Experience With Primary Repair and Selective ... These results suggest that primary repair is a safe option in anatomically suitable patients and support a selective, patient-tailored approach ...

8. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.91.2.566

Guidelines for Carotid Endarterectomy | Circulation (1) Proven: one or more TIAs in the past 6 months and carotid stenosis ≥70% or mild stroke within 6 months and a carotid stenosis ≥70%; (2) acceptable but not ...