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Trial record 1 of 1 for:    NCT02171065
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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 : Unknown
Verified May 2018 by Uppsala University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE June 19, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date May 9, 2018
Actual Study Start Date  ICMJE June 2014
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial.
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Acute Coronary Syndrome (ACS)
Intervention  ICMJE
  • Device: sham
  • Device: ABSORB BVS
Study Arms  ICMJE
  • Sham Comparator: Guideline Directed Medical Therapy
    Guideline Directed Medical Therapy
    Intervention: Device: sham
  • Active Comparator: ABSORB BVS + Guideline Directed Medical Therapy
    ABSORB BVS + Guideline Directed Medical Therapy
    Intervention: Device: ABSORB BVS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 3, 2018)
902
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2014)
900
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02171065
Other Study ID Numbers  ICMJE PROSPECT II & PROSPECT ABSORB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE
  • Abbott Medical Devices
  • InfraReDx
  • The Medicines Company
Investigators  ICMJE
Study Chair: David Erlinge, MD, PhD Lund University
PRS Account Uppsala University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP