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PROTECT II: A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP)in Patients Undergoing Non Emergent High Risk PCI

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Trial Conditions
  • Coronary Artery Disease
What is the purpose of this trial?

The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.

Date & Status

Terminated

Who can Participate?

Eligibility

Ages:
18  - 90 

Gender:
Both

Eligibility

Inclusion Criteria:

- Informed consent

- Subject is indicated for a NON emergent percutaneous treatment of at least on de novo
or restenotic lesion in a native coronary vessel or bypass graft.

- Patient presents with:

- A compromised Ejection Fraction

- Intervention on the last patent coronary conduit

- Intervention on an unprotected left main artery or

- Patient presenting with triple vessel disease.

Exclusion Criteria:

- ST elevation M.I.

- Pre procedure cardiac arrest within 24 hours.

- Subject in cardiogenic shock

Gender: Both
Steward Physician(s)
  • William O'Neill
Trial Interventions
Device
  • IMPLELLA LP 2.5
  • IABP Intra-aortic balloon pump
Physician Researcher

Investigator Name:

  • William O'Neill

Other Information

Sponsor: Abiomed Inc.
Phase: Phase 3
Trial ID: NCT00562016
Volunteers:  Not Accepting Healthy Volunteers

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