Sirolimus-Eluting Stent for Coronary Artery Disease

(BIOFLOW-48 Trial)

Recruiting at 11 trial locations

Overseen By BIOFLOW-48 Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biotronik, Inc.

Must be taking: Dual antiplatelet therapy

Must not be taking: Oral anticoagulation therapy

Disqualifiers: Pregnancy, Stroke, Renal impairment, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System, a small tube used to treat narrow or weak arteries, to determine its safety and effectiveness for people with coronary artery disease. It focuses on patients with specific types of artery blockages in the heart. Ideal participants are those diagnosed with ischemic heart disease, which can cause chest pain or silent heart problems, and are candidates for procedures like angioplasty, where doctors open blocked arteries. As an unphased trial, this study offers patients the opportunity to contribute to important research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be eligible for dual antiplatelet therapy (DAPT) and cannot be on oral anticoagulation therapy unless DAPT and OAC can be maintained together.

What prior data suggests that the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System is safe for treating coronary artery disease?

Research has shown that the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System is generally safe for patients. This stent, already approved to widen coronary arteries in individuals with heart disease, including those with diabetes, suggests it is well-tolerated.

However, the stent may not be suitable for everyone. Individuals allergic to the materials in the stent should avoid its use. Although widespread reports of serious side effects have not emerged, discussing any concerns with a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System is unique because it incorporates sirolimus, a drug that helps reduce scar tissue formation, directly into the stent. Unlike traditional bare-metal stents or even some drug-eluting stents that use different medications, this stent releases sirolimus over a longer period, which can enhance healing and minimize the risk of the artery re-narrowing. Researchers are excited because this delivery method could lead to better long-term outcomes for patients with coronary artery disease by reducing complications and improving arterial health.

What evidence suggests that the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System is effective for coronary artery disease?

Research has shown that the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System, which participants in this trial will receive, improves blood flow in people with coronary artery disease. This stent releases sirolimus, a drug that prevents the arteries from narrowing again after the procedure. Studies have found that it effectively widens the coronary arteries, even in people with diabetes. Designed to treat long buildups of plaque in the arteries, the stent has demonstrated effectiveness across different patient groups, making it a promising option for those needing heart disease treatment. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with long coronary artery lesions who can consent to the study, are candidates for bypass surgery or stent placement, eligible for dual antiplatelet therapy, and have signs of heart disease. They must be willing to follow up for 2-5 years. Those with only one target lesion in a native coronary artery qualify; treatment of an additional non-target lesion is allowed under certain conditions.

Inclusion Criteria

I have heart disease, including stable or unstable chest pain or silent ischemia.

I understand the study and can sign the consent form.

I can give oral consent if I'm unable to sign the form due to my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the index procedure involving the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the index procedure

2 years (US) / 5 years (outside US)

Visits at 1, 6, 12 months and 2 years (US); additional visits at 3 and 5 years (outside US)

What Are the Treatments Tested in This Trial?

Interventions

• Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System

Trial Overview The Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System is being tested for safety and effectiveness in treating patients with specific types of blockages in their heart's arteries. The study involves following U.S. patients for two years and international patients up to five years after the procedure.

How Is the Trial Designed?

Group I: Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Biotronik, Inc.

Lead Sponsor

Trials

41

Recruited

55,000+

Biotronik AG

Industry Sponsor

Trials

47

Recruited

22,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06779630

Safety and Effectiveness of the Orsiro Mission 48-mm ... The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170030B.pdf

summary of safety and effectiveness data (ssed) Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06779630?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Biotronik%20AG%22)&viewType=Table&rank=1

Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

4. trialx.com trialx.com/clinical-trials/listings/315582/safety-and-effectiveness-of-the-orsiro-mission-48-mm-sirolimus-eluting-coronary-stent-system-in-subjects-with-coronary-artery-lesions-bioflow-48-study/

Safety and Effectiveness of the Orsiro Mission 48-mm ... Overview. The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent ...

5. us.orsiro.com us.orsiro.com/orsiro

Orsiro DES Orsiro DES is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable ...

6. biotronik.com biotronik.com/en-us/products/vascular-intervention/coronary-vascular-intervention/orsiro-mission

Orsiro®Mission Orsiro Mission DES is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease.