Is NCT06271590 recruiting in Clearwater, FL?

Yes, NCT06271590 is currently recruiting participants at its Clearwater, FL location. This coronary artery disease clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Clearwater, 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 Clearwater 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 Clearwater, FL

About This Coronary Artery Disease Study in Clearwater

This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.

Sponsor: Concept Medical Inc.

Who Can Participate

Inclusion Criteria

Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, FFR ≤0.80, or non-hyperemic pressure ratio \[NHPR\] ≤0.89 must be present)

Subject is ≥18 and \<80 years old

Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent Angiographic Inclusion Criteria:

Target reference vessel diameter (visual estimation) ≤2.75 mm

Successful lesion preparation (residual stenosis \<30%), without flow-limiting complications (no or slow flow, dissection etc.)

Target lesion(s) in a native coronary artery

Up to two small vessel target lesions in two different vessels

Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon

Target lesion diameter stenosis (visual estimation) \>30% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥2 Clinical

Exclusion Criteria

Planned (staged) intervention in the target vessel

ST-segment-elevation MI within 48 hours prior to index procedure

Subjects with acute cardiac decompensation or cardiogenic shock

Subject with a life expectancy of less than 24 months

Impaired renal function (glomerular filtration rate \[GFR\] \<30 mL/min)

Documented left ventricular ejection fraction (LVEF) ≤30%

Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 \[Zotarolimus\], biolimus, tacrolimus)

Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed)

Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor

If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath

Hemoglobin \<9 g/dL

Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3

White blood cell count \<3,000 cells/mm3

Active infection undergoing treatment

Clinically significant liver disease

Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA

Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaledsteroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)

Subject is unlikely to comply with the follow up requirements, per investigator's assessment

Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached

Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study Angiographic Exclusion Criteria: All exclusion criteria apply to the target lesion(s) or target vessel(s)

Re-stenotic lesion(s), whether due to percutaneous old balloon angioplasty (POBA) or prior stenting

True bifurcation lesion (lesion involves both main and side branch\>2.5 mm) with planned treatment of both branches per investigator assessment

Angiographic evidence of thrombus in the target vessel

Myocardial bridging

Target lesion is heavily calcified

Diffuse distal disease to target lesion with impaired runoff, TIMI flow \<2

Non-target lesion in the target vessel requiring PCI Note: Non-target vessel PCI is allowed at the time of index procedure if performed prior to study intervention and if successful and uncomplicated. For target lesions located in branches of the three main vessels (left anterior descending artery \[LAD\], left circumflex artery \[LCx\], right coronary artery \[RCA\]), the term target vessel refers to the branch and not the main vessel.

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 Clearwater?

Yes, this clinical trial (NCT06271590) has an active research site in Clearwater, FL 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 Clearwater, FL

If you're searching for coronary artery disease treatment options in Clearwater, FL, this clinical trial (NCT06271590) 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 Clearwater 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 Clearwater, FL

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