A Non-Randomized, Unblinded, Singlecenter, First-in-Man, Prospective Forward-Looking (FL) Intravascular Ultrasound (IVUS) Catheter Safety and Feasibility Study in Patients Scheduled for Coronary Stenting.

A Non-Randomized, Unblinded, Singlecenter, First-in-Man, Prospective Forward-Looking (FL) Intravascular Ultrasound (IVUS) Catheter Safety and Feasibility Study in Patients Scheduled for Coronary Stenting. - PreView

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35563

Enrollment

Registered

2010-07-14

Start date

2010-05-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chest pain coronary heart disease

Interventions

The key feature of the Volcano FL.IVUS catheter to be used in this feasibility trial is its ability to obtain a forward-looking view of the vascular anatomy in front of the distal tip of the cathete

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Stable patients scheduled to undergo single vessel coronary stenting due to symptoms of stable angina. Patient must be between the ages of 21 and 85 years old. Patient must be able to read, understand and sign the informed consent document before the planned procedure.

Exclusion criteria

Exclusion criteria: -. Planned surgical percutaneous coronary intervention within 30 days. -. Severe vascular disease, tortuosity, or angiographic evidence of thrombus. -. A recent MI -. Braunwald classification of unstable angina AI, II and III. (see Appendix 3) -. Mainstem leasion -. Ostial lesions. -. Bifurcation lesions double guide wires. -. Total occlusions. -. Left ventricular ejection fraction (LVEF) of less than 30% -. Clinically significant valvular disease. -. CVA. -. Persistent, uncontrolled hypertension -. Hemodynamic instability -. Significant (as determined by the investigator) gastro-intestinal bleeding in the past 3 months. -. Contra-indication to antithrombotic regimen of anticoagulation therapy. -. Patient is known that susceptible to vascular spasm.

Design outcomes

Primary

Measure	Time frame
Safety To evaluate the acute, and immediately post-imaging safety of the Volcano PreView FL.IVUS catheter in vivo. This will be assessed by inserting the catheter into the coronary artery after successful and uncomplicated coronary stenting, imaging the stent and the artery just distal and proximal to the stent, followed by the withdrawal of the catheter. Efficacy Clinical success will be assessed by evaluating the ability of the Volcano PreView FL.IVUS catheter to visualize the vessel wall (in particular, the medial layers), lumen and stent struts in coronary arteries.	—

Measure

Time frame

Safety To evaluate the acute, and immediately post-imaging safety of the Volcano PreView FL.IVUS catheter in vivo. This will be assessed by inserting the catheter into the coronary artery after successful and uncomplicated coronary stenting, imaging the stent and the artery just distal and proximal to the stent, followed by the withdrawal of the catheter. Efficacy Clinical success will be assessed by evaluating the ability of the Volcano PreView FL.IVUS catheter to visualize the vessel wall (in particular, the medial layers), lumen and stent struts in coronary arteries.

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Secondary

Measure	Time frame
The second primary objective of this study is to demonstrate the technical feasibility of imaging and evaluate the efficacy of the Preview FL.IVUS catheter and system.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)