Esprit BTK System for Critical Limb Ischemia

(EspritBTKPAS Trial)

Recruiting at 48 trial locations

Overseen By Rebecca Maslow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Life expectancy ≤ 1 year, Unsalvageable limb, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate procedure

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Esprit BTK System treatment for Critical Limb Ischemia?

Research shows that drug-eluting stents, like the Esprit BTK System, have been effective in treating below-the-knee artery blockages, which are common in Critical Limb Ischemia. These stents help keep arteries open and reduce the chance of them narrowing again. ^{1 2 3 4 5}

Is the Esprit BTK System generally safe for humans?

The Esprit BTK System, which uses a bioresorbable everolimus-eluting scaffold, has been studied in other conditions like coronary artery disease. Some studies suggest it may have risks like stent thrombosis (blood clots in the stent), but more research is needed to fully understand its long-term safety. ^{1 2 5 6 7}

How is the Esprit BTK System treatment different from other treatments for critical limb ischemia?

The Esprit BTK System is unique because it uses a bioresorbable scaffold that releases everolimus, a drug that helps prevent the re-narrowing of blood vessels, and the scaffold gradually dissolves over time, unlike traditional metal stents that remain in the body permanently. ^{1 4 8 9 10}

Research Team

Brian DeRubertis

Principal Investigator

New York Presbyterian/Cornell, New York, NY

Ramon Varcoe

Principal Investigator

Prince of Wales Private Hospital, Randwick, NSW, Australia

Sahil Parikh

Principal Investigator

New York Presbyterian Hospital, New York, NY

Eligibility Criteria

This trial is for patients with Critical Limb Ischemia (CLI), specifically those with diseased blood vessels below the knee. Participants should be suitable for the Esprit BTK System treatment and available for follow-up. The study excludes individuals who don't meet these criteria or have conditions that might interfere with the study results or their safety.

Inclusion Criteria

My target lesion has more than 70% narrowing.

I have severe leg pain due to poor blood flow in my lower legs.

Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.

Exclusion Criteria

Subject is unable or unwilling to provide written consent prior to enrollment.

Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).

Subject is currently participating in another clinical investigation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Esprit BTK Everolimus Eluting Resorbable Scaffold System for treatment of infrapopliteal lesions

Immediate procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits

Extended Follow-up

Participants are monitored for long-term effectiveness and safety

1 year

Treatment Details

Interventions

• Esprit BTK System

Trial Overview The trial is observing how safe and effective the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is in real-world use. It's a single-arm study, meaning all participants receive the same intervention without comparison to a control group.

Participant Groups

Group I: Esprit BTK System Experimental Treatment 1 Intervention

This device, manufactured by Abbott Medical, is intended to be used for improving luminal diameter in infrapopliteal lesions in patients with CLTI.

Esprit BTK System is already approved in United States for the following indications:

Approved in United States as Esprit BTK Everolimus Eluting Resorbable Scaffold System for:

• Improving luminal diameter in infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI)

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

In a trial involving 30 patients with coronary artery lesions, the fully resorbable everolimus-eluting scaffold showed a low rate of major adverse cardiac events (MACE) at 3 years, with only 3.4% experiencing complications.

Importantly, there were no reported cases of stent thrombosis, indicating a favorable safety profile for this novel therapy over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. Onuma, Y., Serruys, PW., Ormiston, JA., et al.[2022]

Drug-coated devices, specifically drug-eluting stents (DES), show improved angiographic outcomes in treating below-the-knee (BTK) lesions in patients with critical limb ischemia (CLI), compared to bare metal stents, particularly in terms of primary patency and restenosis rates.

Despite the promising angiographic results, clinical outcomes for DES in BTK revascularization remain unclear, and there are concerns about complications such as stent fractures that could lead to increased restenosis rates, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the use of drug eluting stents in below-the-knee lesions. Trombert, D., Caradu, C., Brizzi, V., et al.[2016]

The study involving 49 STEMI patients demonstrated that implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS) was highly successful, achieving a procedural success rate of 97.9% and restoring TIMI-flow III in 91.7% of patients after the procedure.

At the 30-day follow-up, there were no cases of target-lesion failure, cardiac death, or scaffold thrombosis, indicating that BVS implantation is a safe and effective option for treating acute myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study. Diletti, R., Karanasos, A., Muramatsu, T., et al.[2022]

The everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) showed excellent safety and effectiveness in treating infrapopliteal atherosclerotic disease, with no major complications such as amputation or death within 30 days of the procedure for the 48 patients studied.

At midterm follow-up (average 24 months), the BVS demonstrated high primary patency rates (81.1% at 36 months) and significant clinical improvement in 93% of limbs, with complete wound healing achieved in 92% of cases treated for tissue loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries. Varcoe, RL., Thomas, SD., Lennox, AF.[2019]

In a study involving 5,583 patients followed for an average of 2 years, bioresorbable vascular scaffolds (BVS) were found to have a significantly higher risk of target lesion failure (9.6% vs. 7.2%) compared to metallic everolimus-eluting stents (EES).

BVS also showed a much higher incidence of stent thrombosis (2.4% vs. 0.7%), indicating that while both devices are used for coronary interventions, BVS may pose greater safety risks over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents. Sorrentino, S., Giustino, G., Mehran, R., et al.[2017]

The study analyzed 951 adverse events related to stent use, finding that stent thrombosis (ST) occurred more frequently with the bioabsorbable polymer-based everolimus-eluting stent (BP-DES) compared to durable polymer drug-eluting stents (DP-DES), with a significant difference (P=0.00001).

Of the ST events associated with BP-DES, a notable 68% occurred within 24 hours of the procedure, suggesting a potential early risk that warrants further investigation and monitoring in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent thrombosis with bioabsorbable polymer drug-eluting stents: insights from the Food and Drug Administration database. Khan, AR., Tripathi, A., Farid, TA., et al.[2022]

A meta-analysis of 12 studies involving 11,692 patients found that biodegradable polymer drug-eluting stents (BP-DES) have a similar risk of stent thrombosis compared to biocompatible polymer everolimus-eluting stents (EES), indicating that BP-DES do not significantly reduce this risk.

There were no significant differences in major clinical outcomes such as all-cause mortality, myocardial infarction, or target vessel revascularization between BP-DES and EES, suggesting that both types of stents provide equivalent clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of biodegradable polymer drug-eluting stents versus biocompatible polymer everolimus-eluting stents: a meta-analysis. Shang, YZ., Li, BY., Feng, Y., et al.[2019]

The Bioresorbable Vascular Scaffold (BVS) is designed to provide temporary support in coronary arteries and is resorbed over a period of 2 to 5 years, representing a significant advancement in heart procedures.

However, there are risks associated with its use, as demonstrated by two cases of late scaffold thrombosis occurring at 20 and 24 months post-implantation, potentially due to strut fractures leading to malapposed struts and subsequent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late Strut Fracture Within a Partially Resorbed Bioresorbable Vascular Scaffold: A Possible Cause of Late Scaffold Thrombosis and Acute Coronary Syndrome. Asrar Ul Haq, M., Erickson, M., Rankin, J., et al.[2022]

Patients treated with bioresorbable vascular scaffolds (BVS) had a significantly higher risk of definite/probable device thrombosis (DT) compared to those treated with everolimus-eluting stents (EES), with an odds ratio of 2.93 based on a meta-analysis of 5 trials involving 1730 patients.

There was a trend indicating that BVS patients had a higher risk of target lesion failure (TLF), primarily due to increased rates of myocardial infarction and revascularization, although no significant difference in cardiac death was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late thrombotic events after bioresorbable scaffold implantation: a systematic review and meta-analysis of randomized clinical trials. Collet, C., Asano, T., Miyazaki, Y., et al.[2022]

In a pilot study involving 20 patients with ST segment elevation myocardial infarction (STEMI), both the metallic everolimus-eluting stent (Synergy) and the bioresorbable vascular scaffold (Absorb) showed nearly complete arterial healing after 3 months, indicating their safety in this acute setting.

The Synergy stent demonstrated lower neointimal thickness and in-stent obstruction compared to the Absorb scaffold, but the Absorb scaffold had a higher rate of uncovered struts, suggesting different healing responses that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study. Lhermusier, T., Ohayon, P., Boudou, N., et al.[2020]

References

1. France pubmed.ncbi.nlm.nih.gov

Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Evidence for the use of drug eluting stents in below-the-knee lesions. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevation myocardial infarction: BVS STEMI first study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Stent thrombosis with bioabsorbable polymer drug-eluting stents: insights from the Food and Drug Administration database. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effect of biodegradable polymer drug-eluting stents versus biocompatible polymer everolimus-eluting stents: a meta-analysis. [2019]

8. Australia pubmed.ncbi.nlm.nih.gov

Late Strut Fracture Within a Partially Resorbed Bioresorbable Vascular Scaffold: A Possible Cause of Late Scaffold Thrombosis and Acute Coronary Syndrome. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Late thrombotic events after bioresorbable scaffold implantation: a systematic review and meta-analysis of randomized clinical trials. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study. [2020]