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New treatment option for Coronary Artery Disease
Official title SELUTION 4 De Novo Small Vessel IDE Trial
ClinicalTrials.gov ID: NCT05946629
What this study is testing
- What it's testing
- Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe.
- Which group you join is decided by chance.
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
- Clinical people must meet all of the following clinical criteria to participate in the trial:
- Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
- Female people of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
- Subject presents with chronic coronary syndromes [CCS] (manifest as documented angina or positive functional testing), unstable angina or stabilized...
- Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For people requiring oral...
You likely can't join if
- Clinical Exclusion Criteria people who meet any of the following clinical criteria will be excluded from the trial:
- Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
- Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
- Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
- Subject with planned major surgery within 30 days following the index procedure.
- Subject with planned treatment of lesion involving aorto-ostial location.
See the full eligibility criteria
Who can join
- Clinical people must meet all of the following clinical criteria to participate in the trial:
- Subject is ≥ 18 years (or the minimum legal age as required by local regulations).
- Female people of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.
- Subject presents with chronic coronary syndromes [CCS] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized...
- Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For people requiring oral anticoagulation, aspirin may be omitted based on investigator discretion).
- Subject has life expectancy \> 1 year in the opinion of the investigator.
- Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. PK Sub- Study people must meet all of the main protocol to participate in the PK sub-study...
- A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be...
- Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion.
- Target lesion is ≤ 36 mm in length.
- Target lesion has diameter stenosis \> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2.
- Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm [by visual assessment].
- Target lesion is within a native coronary artery or major branch.
- A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated.
- The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment.
What rules you out
- Clinical Exclusion Criteria people who meet any of the following clinical criteria will be excluded from the trial:
- Subject with known hypersensitivity or allergy to Sirolimus or its analogues.
- Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.
- Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.
- Subject with planned major surgery within 30 days following the index procedure.
- Subject with planned treatment of lesion involving aorto-ostial location.
- Subject with PCI of a non-target vessel within ± 30 days of the index procedure.
- Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure.
- Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT).
- Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure.
- people with current documented left ventricular ejection fraction (LVEF) \< 30%.
- Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated.
- people is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
- Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure.
- Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate [GFR] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or had undergone renal transplantation. PK Sub-Study Exclusion...
- Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index...
- Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \>30 days after index procedure...
- The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.
- Subject is concurrently enrolled in the main protocol angiographic registry.
- people who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and...
- people who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide...
- Angiographic Exclusion Criteria Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial:
- Target lesion is totally occluded or has evidence of thrombus.
- Target lesion is located in the left main or any arterial or venous graft.
- Target lesion is in a side branch that is "jailed" by a main vessel stent.
- In stent restenosis
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Chula Vista, California, United States
- Los Angeles, California, United States
- Thousand Oaks, California, United States
- Torrance, California, United States
- Golden, Colorado, United States
- Thornton, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Atlantis, Florida, United States
- Bradenton, Florida, United States
- Clearwater, Florida, United States
- Jacksonville, Florida, United States
- Largo, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Trinity, Florida, United States
- Atlanta, Georgia, United States
- Dalton, Georgia, United States
- Thomasville, Georgia, United States
+ 42 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 Jonesboro, Arkansas, United States; Chula Vista, California, United States; Los Angeles, California, United States; Thousand Oaks, California, United States; Torrance, California, United States; Golden, Colorado, United States and 56 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.