FORWARD CAD IDE Study
ConditionCoronary Arterial Disease (CAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShockwave Medical, Inc.
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.
Eligibility criteria
Qualifiers
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)
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intravascular Lithotripsy
Treatment groups
408 Participants
are divided into 1 treatment groupLocations
34United Kingdom
Basildon University HospitalSS16 5NL, BasildonUK, United Kingdom
Bristol Heart InstituteBS2 8ED, BristolUK, United Kingdom
Leeds Teaching Hospital NHS TrustLS1 3EX, LeedsUK, United Kingdom
Glenfield HospitalLE3 9QP, LeicesterUK, United Kingdom
Sponsors and collaborators
Shockwave Medical, Inc.
Lead sponsor
Source ClinicalTrials.gov