PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial. (P2)
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|ClinicalTrials.gov Identifier: NCT02171065|
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 10, 2021
Last Update Posted : August 10, 2021
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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.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Troponin positive ACS (STEMI >12 h or NSTEMI) occurring within the prior 4 weeks of enrollment, with symptoms consistent with acute ischemia lasting >10 minutes, intended for angiography and Percutaneous Coronary Intervention (PCI) if appropriate.
- Patient must have one-vessel, two-vessel or three-vessel disease in native coronary arteries requiring PCI.
- Successful PCI
- Known estimated creatinine clearance <30 ml/min.
- Cardiogenic shock, decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or a hemodynamic support device.
- Patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, both heparin and bivalirudin, all 3 of clopidogrel, prasugrel and ticagrelor, or to contrast that cannot be adequately pre-medicated.
- Refractory ventricular arrhythmias (e.g. ventricular tachycardia or fibrillation) requiring either intravenous pharmacologic treatment or defibrillation during the index PCI procedure.
- Persistent acute conduction system disease requiring temporary pacemaker insertion during the index PCI procedure.
- Prior Coronary Artery Bypass Graft (CABG) at any time or planned CABG.
- PCI is required of the left main coronary artery, or a left main stenosis is present with a visually estimated angiographic Diameter Stenosis (DS) of >30%.
- Angiographic evidence of severe calcification and/or marked tortuosity of the target (culprit) or a non-culprit vessel is present that would preclude the feasibility of safe imaging of at least the proximal 6 cm of all vessels.
- The presence of a chronic total occlusion of a major epicardial coronary vessel that is not successfully recanalized during the PCI procedure, and thus would preclude intravascular imaging.
if one or more eligible lesions are identified which meet all of the following angiographic criteria:
- The lesion is a de novo lesion (may be located in either the target or non-target vessel)
The lesion has an angiographic diameter stenosis <70%, and is not intended for revascularization based on angiographic criteria and Fractional Flow Reserve/Instantaneous wave-free ratio (FFR/iFR).
Note: FFR/iFR should be performed on all noncritical lesions of greater than 40% visually estimated angiographic stenosis that are candidates for the ABSORB substudy.
- The lesion has a site-determined IVUS plaque burden in at least one frame ≥65%. Note: Such a lesion may or may not be angiographically evident; i.e. the visually estimated angiographic diameter stenosis may range between 0% - <70%.
- The reference vessel diameter of an eligible lesion is ≥2.5 mm - ≤4.0 mm (visually estimated) capable of being treated with a 2.5 mm, 3.0 mm, or 3.5 mm diameter BVS.
- The lesion length of an eligible lesion is ≤50 mm (visually estimated), capable of being treated by no more than two BVS (maximum length of each BVS 28 mm), allowing for 2 mm BVS overlap and 2 mm of "normal" reference segment treatment at each edge.
- The lesion must be at least 10 mm from a previously implanted stent/scaffold and an intervening 10 mm segment must not have plaque burden (PB) >50%
- A bifurcation lesion may be enrolled only if the side branch is a) ≤2.5 mm in reference vessel diameter, AND b) has either no lesion requiring treatment, or atherosclerotic disease limited to within 5 mm of its origin from the parent vessel such that the operator believes that the side branch can be successfully treated with balloon angioplasty only (without a stent). If a stent subsequently becomes necessary, only a metallic drug-eluting stent (DES) may be used to treat the side branch with a T-stent technique.
- Randomization must occur immediately after the 3-vessel imaging run in the PROSPECT II protocol. If the patient randomizes to BVS, BVS placement must be performed immediately after randomization.
- The randomized lesion cannot be within 10 mm of a lesion previously treated by PCI .
- The randomized lesion may not be in the left main coronary artery.
- The randomized lesion may not be an ostial Left Anterior Descending Coronary Artery (LAD) or ostial Left Circumflex Coronary Artery (LCX) lesion (defined as within 3 mm of the left main coronary artery).
- The randomized lesion may not be an ostial Right Coronary Artery (RCA) lesion (defined as within 3 mm of the aorto-ostium).
- Angiographic evidence of severe calcification and/or marked tortuosity of the target vessel and/or lesion intended for randomization is present that would make it unlikely that the BVS could be advanced to or across the lesion or be adequately expanded.
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|
Documents provided by Uppsala University:
|Responsible Party:||Uppsala University|
|Other Study ID Numbers:||
PROSPECT II & PROSPECT ABSORB
|First Posted:||June 23, 2014 Key Record Dates|
|Results First Posted:||August 10, 2021|
|Last Update Posted:||August 10, 2021|
|Last Verified:||July 2021|
Acute Coronary Syndrome