PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial. (P2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02171065|
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 10, 2021
Last Update Posted : August 10, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome (ACS)||Device: sham Device: ABSORB BVS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||902 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Multicentre Prospective Natural History Study Using Multimodality Imaging in Patients With ACS- PROSPECT II (Natural History Study), Combined With a Randomized, Controlled, Intervention Study - PROSPECT ABSORB (Randomized Trial)|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||May 2020|
|Actual Study Completion Date :||May 2020|
Sham Comparator: Guideline Directed Medical Therapy
Guideline Directed Medical Therapy
Active Comparator: ABSORB BVS + Guideline Directed Medical Therapy
ABSORB BVS + Guideline Directed Medical Therapy
Device: ABSORB BVS
- Prospect II: Patient Level Non-culprit Lesion Related Non-Culprit Major Adverse Cardiac Event (NC-MACE) Adjudicated to an Originally Untreated Non-culprit Lesion During the Entire Study Duration [ Time Frame: Median follow-up of 3.7 (first quartile, third quartile; 3.0, 4.4) years ]Patient-level rate of non-culprit lesion-related MACE (NC-MACE) evaluated at the longest follow-up available, assessed at the time when the last patient enrolled reaches at least 24 months. NC-MACE is defined as an event arising from an originally untreated NC lesion consisting of the composite of 1) cardiac death, 2) myocardial infarction, 3) unstable angina, or 4) progressive angina or anginal equivalent symptoms either 4a) requiring revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), and/or 4b) with angiographic core lab-confirmed rapid lesion progression.(NC-MACE).
- Prospect Absorb: The Minimum Luminal Area (MLA) at the Randomized Non-culprit Lesion Site in Patients Treated With the ABSORB BVS + GDMT Compared to GDMT Only Measured at 25 Months [ Time Frame: 25 month ]The MLA at the randomized non-culprit lesion site in patients treated with Absorb BVS + GDMT compared to GDMT only as measured at 25 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171065
|Lund, Sweden, 221 85|
|Study Chair:||David Erlinge, MD, PhD||Lund University|