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PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial. (P2)

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ClinicalTrials.gov Identifier: NCT02171065
Recruitment Status : Active, not recruiting
First Posted : June 23, 2014
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Abbott Medical Devices
InfraReDx
The Medicines Company
Information provided by (Responsible Party):
Uppsala University

Brief 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, Intravascular Ultrasound (IVUS) and Near InfraRed Spectroscopy(NIRS), to identify plaques prone to future rupture and clinical events. Due to the difficulty of interpreting the IVUS images, this study will be, however, using Plaque Burden (PB) ≥65% as the primary threshold defining vulnerable plaques. However, sensitivity analyses will be run for patients and lesions with PB≥70%. The randomized PROSPECT ABSORB sub-study will examine whether treatment of vulnerable plaques with the ABSORB Bioresobable Vascular Scaffold (BVS) plus Guideline Directed Medical Therapy (GDMT) safely increases the Minimal Lumean Diameter (MLA) at 25 month compared with GDMTalone.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome (ACS) Device: sham Device: ABSORB BVS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 902 participants
Allocation: Randomized
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 Acute Coronary Syndromes - PROSPECT II (Natural History Study), Combined With a Randomized, Controlled, Intervention Study - PROSPECT ABSORB (Randomized Trial)
Actual Study Start Date : June 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Sham Comparator: Guideline Directed Medical Therapy
Guideline Directed Medical Therapy
Device: sham
Active Comparator: ABSORB BVS + Guideline Directed Medical Therapy
ABSORB BVS + Guideline Directed Medical Therapy
Device: ABSORB BVS



Primary Outcome Measures :
  1. Patient level non-culprit lesion related Non-Culprit Major Adverse Cardiac Event (NC-MACE) through 2 years adjudicated to an originally untreated non-culprit lesion [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROSPECT II

Inclusion Criteria:

  1. Troponin positive ACS (STEMI >12 h or NSTEMI) occurring within the prior 2 weeks of enrollment, with symptoms consistent with acute ischemia lasting >10 minutes, intended for angiography and Percutaneous Coronary Intervention (PCI) if appropriate.
  2. Patient must have one-vessel, two-vessel or three-vessel disease in native coronary arteries requiring PCI.
  3. Successful PCI

Exclusion Criteria:

  1. Known estimated creatinine clearance <30 ml/min.
  2. Cardiogenic shock, decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or a hemodynamic support device.
  3. 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.
  4. Refractory ventricular arrhythmias (e.g. ventricular tachycardia or fibrillation) requiring either intravenous pharmacologic treatment or defibrillation during the index PCI procedure.
  5. Persistent acute conduction system disease requiring temporary pacemaker insertion during the index PCI procedure.
  6. Prior Coronary Artery Bypass Graft (CABG) at any time or planned CABG.
  7. 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%.
  8. 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.
  9. 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.

PROSPECT ABSORB

Inclusion Criteria:

if one or more eligible lesions are identified which meet all of the following angiographic criteria:

  1. The lesion is a de novo lesion (may be located in either the target or non-target vessel)
  2. 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.

  3. The lesion has a site-determined IVUS plaque burden in at least one frame ≥70%. Note: Such a lesion may or may not be angiographically evident; i.e. the visually estimated angiographic diameter stenosis may range between 0% - <70%.
  4. 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.
  5. 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.
  6. 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%
  7. 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; XIENCE strongly recommended) may be used to treat the side branch with a T-stent technique.
  8. 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.

Exclusion Criteria:

  1. The randomized lesion cannot be within 10 mm of a lesion previously treated by PCI .
  2. The randomized lesion may not be in the left main coronary artery.
  3. 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).
  4. The randomized lesion may not be an ostial Right Coronary Artery (RCA) lesion (defined as within 3 mm of the aorto-ostium).
  5. 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.

Information from the National Library of Medicine

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


Locations
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Sweden
David Erlinge
Lund, Sweden, 221 85
Sponsors and Collaborators
Uppsala University
Abbott Medical Devices
InfraReDx
The Medicines Company
Investigators
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Study Chair: David Erlinge, MD, PhD Lund University

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02171065     History of Changes
Other Study ID Numbers: PROSPECT II & PROSPECT ABSORB
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Keywords provided by Uppsala University:
NIRS/IVUS
multimodality imaging
PROSPECT
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases