Is NCT06662500 recruiting in Boston, MA?

Yes, NCT06662500 is currently recruiting participants at its Boston, MA location. This coronary arterial disease (cad) clinical trial is actively enrolling qualified participants.

How do I join the coronary arterial disease (cad) clinical trial in Boston?

To join this clinical trial in Boston, 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 Boston 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 Arterial Disease (CAD) Clinical Trial in Boston, MA

About This Coronary Arterial Disease (CAD) Study in Boston

The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.

Sponsor: Shockwave Medical, Inc.

Who Can Participate

Inclusion Criteria

Subject is ≥18 years of age

Subject is able and willing to comply with all assessments in the study.

Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)

Biomarkers (troponin) must be:

less than or equal to the upper limit of lab normal within 24 hours prior to the procedure or may be drawn from the side port of the sheath at the time of index if the PCI is a non-emergent procedure and has stable angina (result will not be known prior to procedure); OR

if above the upper limit of lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 24 hours prior to the procedure and the following criteria must be met: • The procedure must not be emergent and the subject cannot have angina at rest.

Left ventricular ejection fraction (LVEF) \>30% within 6 months (note: in the case of an event (MI or Revascularization) the LVEF must be taken post-event and in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure).

Subject, or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures.

Estimated life expectancy \>1 year.

Lesions in non-target vessels requiring PCI may be treated either:

\>30 days prior to the study procedure if the procedure was unsuccessful or complicated; OR

\>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis \<30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and no evidence of elevated biomarkers post-procedure; OR

\>30 days after the study procedure Angiographic Inclusion Criteria

The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure

Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches)

The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

The target lesion must meet one of the following criteria:

Target lesion stenosis \>90% up to 40 mm in length and evidence of moderate or severe calcification at the lesion site. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall; OR

Chronic total occlusion presenting with J-CTO score of 1 with evidence of calcification and occlusion length up to 20 mm.

Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Shockwave Javelin Coronary IVL catheter (antegrade wire technique only) General

Exclusion Criteria

Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits

Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint

Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)

Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines

Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated

Subject experienced an acute STEMI within 30 days prior to index procedure

New York Heart Association (NYHA) class III or IV heart failure

Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73m2 (using institutional formula)

History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit

Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months

Untreated pre-procedural hemoglobin \<10 g/dL or intention to refuse blood transfusions if one should become necessary

Coagulopathy, including but not limited to platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)

Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders

Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics

Subjects with clinical evidence of cardiogenic shock

Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)

Subjects with an estimated life expectancy of less than 1 year

Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure

Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure

Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery

Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL Angiographic Exclusion Criteria

Unprotected left main diameter stenosis \>30%

Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (dissection, perforation, abrupt closure, persistent slow-flow or persistent no reflow)

Definite or possible thrombus by angiography in the target vessel

Evidence of aneurysm in target vessel within 10 mm of the target lesion

Second lesion with \>50% stenosis in the same target vessel as the target lesion including its side branches

Chronic total occlusion of the target lesion, J-CTO ≥2

Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft

Previous stent within 5 mm of the target lesion

Failure to successfully cross the guidewire across the target lesion

Planned use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.

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 Boston?

Yes, this clinical trial (NCT06662500) has an active research site in Boston, MA 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 Arterial Disease (CAD) Treatment Options in Boston, MA

If you're searching for coronary arterial disease (cad) treatment options in Boston, MA, this clinical trial (NCT06662500) 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 Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced coronary arterial disease (cad) 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 arterial disease (cad) clinical trials near you to find additional studies recruiting in your area.

Coronary Arterial Disease (CAD) Clinical Trial in Boston, MA

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