Evaluating the Safety And Effectiveness of the Valet Micro Catheter

A Non-Randomized, Non-blinded, Prospective Feasibility Study to Assess the Safety and Effectiveness of the Volcano Valet Micro Catheter in Patients with Coronary or Peripheral Artery Disease (CAD/PAD) Scheduled for Diagnostic Angiogram or Intervention

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000009819

Acronym

SAFE

Enrollment

Registered

2012-01-04

Start date

2012-01-09

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

To assess the safety and effectiveness of the Volcano Valet Micro Catheter in patients with coronary or peripheral artery disease (CAD/PAD) scheduled for diagnostic angiogram or intervention.

Interventions

The Valet Micro Catheter is intended as a single use device during the interventional procedure as a conduit for the exchange/ support of guide wires in the peripheral and coronary vasculatures. Valet micro catheters are indicated to infuse and deliver saline and/or contrast agents. The device is expected to be in the body for less than 15 minutes.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

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.

Outcome results