Evaluating the Safety And Effectiveness of the Valet Micro Catheter

Not Applicable

• Conditions: Peripheral Artery Disease (PAD); Cardiovascular - Coronary heart disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Coronary Artery Disease (CAD)

• Registration Number: ACTRN12612000009819
• Lead Sponsor: Volcano Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Stable patients with varying degrees of CAD or PAD scheduled for diagnostic angiogram or intervention.

Patient must be able to read, understand and sign the informed consent document before the planned procedure.

Exclusion Criteria

Coronary (CAD) patients will be excluded if they meet any of the following criteria:

Acute Coronary Syndrome (unstable, NSTEMI and STEMI) within 5 days of the procedure.

Patients with unprotected Left Main (LM) disease or ostial lesions of >50%.

Patients at higher risk as determined by the physician.

Patients with an ejection fraction of less than 30% as determined by echo or ventriculogram.

Patients with a saphenous vein graft(s).

Patients who are pregnant or would be at risk from ionizing radiation.

History of or known reaction or sensitivity to contrast agent and is unable to be premedicated.

Peripheral (PAD) patients will be excluded if they meet any of the following criteria:

Acute Coronary Syndrome (unstable, NSTEMI and STEMI) within 5 days of the procedure.

Patients with saphenous vein grafts, if on the ipsilateral side.

Patients with acute limb ischemia.

History of or known reaction or sensitivity to contrast agent and is unable to be premedicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified