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Tests treatment safety and results for Coronary Artery Disease
Official title Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
ClinicalTrials.gov ID: NCT06779630
What this study is testing
- What it's testing
- 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 subjects with atherosclerotic lesion(s) \>36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm. Patients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is ≥ 18 years of age
- Subject is able to understand the nature of the study and provide written informed consent. For sites outside of the United States: Note: For people...
- Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
- Subject is an acceptable candidate for CABG.
- Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
You likely can't join if
- For sites in United States only: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial...
- Subject is hemodynamically unstable.
- Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
- Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin...
- Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within \<72 hours prior...
- Future planned PCI (including staged procedure) or CABG after the index procedure.
See the full eligibility criteria
Who can join
- Subject is ≥ 18 years of age
- Subject is able to understand the nature of the study and provide written informed consent. For sites outside of the United States: Note: For people presenting with STEMI and not in a position to read, interpret and...
- Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
- Subject is an acceptable candidate for CABG.
- Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
- Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
- Subject is willing and able to comply with study follow-up requirements. Angiographic
- Subject has only one target lesion in a native coronary artery to be treated with the investigational device. Note: One additional non-target lesion may be treated with a non-investigational treatment (e.g. stent...
- Target lesion must be \> 36 mm and ≤ 44 mm in length by operator visual estimate and must be amenable to treatment with a single study device.
- Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
- For sites in United States: Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only. For sites outside of the United States...
- Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate which may be assisted by QCA / IVUS / OCT). Target lesion stenosis \< 70% should have clinical justification for...
- Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \> 1. For sites outside of the United States: Note: For STEMI, TIMI flow \> 1 prior to stent implantation (after opening the vessel with a...
What rules you out
- For sites in United States only: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note...
- Subject is hemodynamically unstable.
- Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
- Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its...
- Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within \<72 hours prior to the index procedure.
- Future planned PCI (including staged procedure) or CABG after the index procedure.
- Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
- History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
- people with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
- Subject will refuse blood transfusions.
- Subject has a left ventricular ejection fraction (LVEF) \< 30% within 6 months prior to or during the index procedure that was documented by any method.
- Subject is dialysis dependent or has impaired renal function (i.e., serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure).
- Subject has a documented white blood cell count \ 700,000 platelets/mm3.
- Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus...
- Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission.
- people under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines.
- Subject has life expectancy of \< 1 year.
- Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.
- In the investigator's opinion, subject will not be able to comply with the follow-up requirements. Angiographic exclusion criteria:
- Target lesion is excluded if it meets any of the following criteria:
- Lesion is located within or treated through a saphenous vein graft or arterial graft.
- Lesion location is within the left main coronary artery.
- Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries.
- Involves a side branch of \> 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
- Lesion is totally occluded (100% stenosis).
- For sites in United States only: Lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).
- Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
- Site sites in the United States: Target vessel has angiographic evidence of thrombus. For sites outside of the United States: Target vessel has angiographic evidence of unresolved large thrombus burden despite of...
- Target vessel was treated with brachytherapy any time prior to the index procedure.
- Unsuccessful target lesion pre-dilatation, defined as residual stenosis \> 50% (by visual estimation) and/or angiographic complications (e.g., distal embolization, side branch closure, dissection greater than National...
- Non-target lesion is excluded if it meets any of the following criteria:
- Any of the target lesion angiographic exclusion criteria except for 1c
- Lesion is located within the target vessel.
- Lesion is \> 36 mm by operator visual estimate.
- Lesion requires additional, unplanned stents to treat a complication.
- Lesion treatment is not deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis \< 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged...
The study team makes the final eligibility decision.
Where it's taking place
- Concord, California, United States
- Wichita, Kansas, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Manhasset, New York, United States
- New York, New York, United States
- Dallas, Texas, United States
- Kyle, Texas, United States
- Charleston, West Virginia, United States
- Vienna, State of Vienna, Austria
- Graz, Styria, Austria
- Lyon, Auvergne-Rhône-Alpes, France
- Essey-lès-Nancy, Grand Est, France
- Saint-Laurent-du-Var, Provence-Alpes-Côte d'Azur Region, France
- Paris, Île-de-France Region, France
- Mannheim, Baden-Wurttemberg, Germany
- Fürth, Bavaria, Germany
- Würzburg, Bavaria, Germany
- Bad Segeberg, Schleswig-Holstein, Germany
- Lubin, Lower Silesian Voivodeship, Poland
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Concord, California, United States; Wichita, Kansas, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Manhasset, New York, United States; New York, New York, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.