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Completed

NCT Number: NCT00534859

PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.

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Key information

Conditions

Patients Undergoing High Risk PCI.

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Academic Medical Center, Amsterdam, Netherland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
  • EF <35%

Exclusion criteria

  • ST Myocardial Infarction
  • Cardiac Arrest
  • Cardiogenic Shock
  • Thrombus Left Ventricle

Treatment and study plan

High Risk PCI

Device

High Risk Percutaneous Coronary Intervention

Primary outcomes

  1. MACCE Events at 30 days or discharge, whichever is longer

    Time frame: 30 days or discharge

    Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.

  2. Freedom from Hemodynamic compromise during PCI procedure

    Time frame: During procedure

    Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required

Secondary outcomes

  1. Other intra-procedural and peri-procedural adverse events

    Time frame: During treatment and out to 90 days

  2. Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion

    Time frame: During procedure

    Freedom from the following procedural-related events:

    i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion

  3. Angiographic Success

    Time frame: Post-PCI

    Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty.

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

Acronym: PROTECT I

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Sep 26, 2007
Registry last updated
Mar 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.