At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Intravascular Lithotripsy (device)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- Intravascular Lithotripsy — device: The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary Catheter is intended to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to balloon crossing, full dilatation or subsequent uniform coronary stent expansion.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 408
- Started
- 2025-04-04
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for coronary arterial disease (cad)
- • NA - 408 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with coronary arterial disease (cad)
Where?
- • Basildon - Basildon University Hospital
- • Bristol - Bristol Heart Institute
- • Leeds - Leeds Teaching Hospital NHS Trust
- • Leicester - Glenfield Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The Shockwave Javelin Coronary IVL Catheter was developed to address the current challenges clinicians face when treating tight, difficult to cross, calcified coronary lesions and was designed as a rapid exchange catheter to deliver intravascular lithotripsy to those complex lesions in the coronary vasculature. The intended benefit of the Shockwave Javelin Coronary IVL Catheter is to allow the catheter to modify calcium in tight, difficult to cross lesions to increase the compliance of the vessel and allow further crossing of the device or additional treatment at the discretion of the physician. Up to 158 subjects (150 evaluable) subjects with moderate-to severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) that are suitable for non-emergent percutaneous coronary intervention (PCI) will be enrolled at up to 35 sites. Once the pivotal cohort is fully enrolled (N=158), the study will continue to enroll an Extended Investigation cohort of up to 250 additional subjects.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
- ✓Biomarkers (troponin) must be:
- ✓Subject, or legally authorized representative, signs a written agreement to take part form to participate in the study,...
Who cannot take part
- ✗Any other health condition 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,...
- ✗Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7...
- ✗Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
- ✗Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
See the full criteria
Where Is This Study? (6 UK sites)
Basildon University Hospital
Basildon SS16 5NL, United Kingdom
Bristol Heart Institute
Bristol BS2 8ED, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds LS1 3EX, United Kingdom
Glenfield Hospital
Leicester LE3 9QP, United Kingdom
St. Thomas Hospital
London SE1 7EH, United Kingdom
St. George's Hospital
London SW17 0RE, United Kingdom
How to Get in Touch
Randee Randoll
Sponsor contactCONTACT
Lesli DeSimone
Sponsor contactCONTACT
