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New treatment option for Coronary Arterial Disease (CAD)
Official title FORWARD CAD IDE Study
ClinicalTrials.gov ID: NCT06662500
What this study is testing
- What it's testing
- 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.
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
- General
- Subject is ≥18 years of age
- Subject is able and willing to comply with all assessments in the study.
- people with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent...
- Biomarkers (troponin) must be:
You likely can't join if
- 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...
- 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
See the full eligibility criteria
Who can join
- General
- Subject is ≥18 years of age
- Subject is able and willing to comply with all assessments in the study.
- people 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...
- 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...
- 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...
- 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...
- \>30 days after the study procedure Angiographic 9. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any treatment 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...
- 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
What rules you out
- 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 \ 1.7 (INR is only required in people 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
- people with clinical evidence of cardiogenic shock
- Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
- people with an estimated life expectancy of less than 1 year
- Non-coronary treatment 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- San Francisco, California, United States
- Littleton, Colorado, United States
- Hartford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Roslyn, New York, United States
- Raleigh, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- York, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Plano, Texas, United States
- Salt Lake City, Utah, United States
+ 7 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 La Jolla, California, United States; San Francisco, California, United States; Littleton, Colorado, United States; Hartford, Connecticut, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States and 21 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.