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Clinical Trials/ACTRN12612000009819
ACTRN12612000009819Not yet recruiting未知

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

Volcano Corporation0 sites15 target enrollmentStarted: January 4, 2012Last updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Not yet recruiting
Enrollment
15
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 85 Years (—)
Sex
All

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.

Investigators

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