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

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)

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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