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PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial.

NCT02171065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 902

Last updated 2021-08-10

Study results available
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Summary

The present study has two components, an overall prospective observational study using multimodality imaging (PROSPECT II) that will examine the natural history of patients with unstable atherosclerotic coronary artery disease with the specific goal to establish the utility of low-risk intracoronary imaging modalities, IVUS and NIRS, to identify plaques prone to future rupture and clinical events. The randomized PROSPECT ABSORB substudy will examine whether treatment of vulnerable plaques with the Absorb Bioresorbable vascular scaffold (BVS) plus GDMT safely increases the minimum lumen area (MLA) at 24 months compared with GDMT alone.

The cutoff for inclusion in PROSPECT ABSORB will be a site-determined PB ≥65% (rather than the 70% cutoff identified in the original PROSPECT analysis (Stone et al., New England Journal of Medicine, 2011(5)) to account for an observed tendency for sites to underestimate plaque burden during acute treatment of ACS patients. Nonetheless, in PROSPECT, a core laboratory determined PB ≥65% was also associated with a high (7.0%) rate of major adverse cardiac event (MACE) during 3-year follow-up, a rate which may be reduced with a bioresorbable scaffold.

Conditions

  • Acute Coronary Syndrome (ACS)

Interventions

DEVICE

sham

DEVICE

ABSORB BVS

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Infraredx

    collaborator INDUSTRY

  • The Medicines Company

    collaborator INDUSTRY

  • Uppsala University

    lead OTHER

Principal Investigators

  • David Erlinge, MD, PhD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02171065 on ClinicalTrials.gov