Is NCT05946629 recruiting in Washington Dc, DC?

Yes, NCT05946629 is currently recruiting participants at its Washington Dc, DC location. This coronary artery disease clinical trial is actively enrolling qualified participants.

How do I join the coronary artery disease clinical trial in Washington Dc?

To join this clinical trial in Washington Dc, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Washington Dc clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Coronary Artery Disease Clinical Trial in Washington Dc, DC

About This Coronary Artery Disease Study in Washington Dc

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. A minimum of 50% of the subjects will be enrolled in the US.

Sponsor: M.A. Med Alliance S.A.

Who Can Participate

Inclusion Criteria

Clinical Inclusion Criteria Subjects 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 subjects 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 or down trending) with an indication for PCI and planned intervention.

Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects 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 Inclusion Criteria: Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria: 1\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations. Imaging Inclusion Criteria Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial:

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 staged for treatment \> 30 days from the index procedure.

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.

Exclusion Criteria

Clinical Exclusion Criteria Subjects 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.

Subjects 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.

Subjects 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 Criteria: Subjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met:

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 procedure.

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 (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.

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.

Subjects 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 ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir.

Subjects 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; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Washington Dc?

Yes, this clinical trial (NCT05946629) has an active research site in Washington Dc, DC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Coronary Artery Disease Treatment Options in Washington Dc, DC

If you're searching for coronary artery disease treatment options in Washington Dc, DC, this clinical trial (NCT05946629) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Washington Dc research site is actively enrolling participants for this clinical trial. You'll receive care from experienced coronary artery disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all coronary artery disease clinical trials near you to find additional studies recruiting in your area.

Coronary Artery Disease Clinical Trial in Washington Dc, DC

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