Protect II, A Prospective, Multicenter Randomized Controlled Trial (PROTECT II)

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Abiomed

Status and phase

Terminated
Phase 3

Conditions

Coronary Artery Disease

Treatments

Device: IMPLELLA LP 2.5
Device: IABP Intra-aortic balloon pump

Study type

Interventional

Funder types

Industry

Identifiers

NCT00562016
7182007

Details and patient eligibility

About

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.

Enrollment

452 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

452 participants in 2 patient groups

IMPELLA LP 2.5
Experimental group
Treatment:
Device: IMPLELLA LP 2.5
IABP Intra-aortic balloon pump
Active Comparator group
Treatment:
Device: IABP Intra-aortic balloon pump

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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