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Trial record 2 of 12 for:    REVELATION

Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction (REVELATION)

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: NCT02219802
Recruitment Status : Unknown
Verified August 2014 by J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Collaborators:
Biotronik SE & Co. KG
Volcano Corporation
Information provided by (Responsible Party):
J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis

Tracking Information
First Submitted Date  ICMJE June 30, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date August 19, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
Fractional flow reserve (FFR) [ Time Frame: At 9 months follow-up ]
Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2014)
  • Major adverse cardiac event (MACE) [ Time Frame: In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up. ]
    1. Cardiac death (ARC); defined as any death in which a cardiac cause cannot be excluded.
    2. Recurrent MI in the target vessel area.
    3. Ischemia driven target lesion revascularization (PCI within 5 mm of the treated segment in case of balloon, or stent area borders in case of stent, or CABG of the target vessel).
  • Angiographic endpoint: iFR [ Time Frame: At 9 months follow-up. ]
  • ST-segment resolution [ Time Frame: 90 minutes after initial procedure ]
    ST-segment resolution post-initial procedure at 90 minutes, defined as the ST-segment deviation resolution in only the single lead showing maximum deviation.
  • Non-coronary artery bypass grafting major bleeding [ Time Frame: At 1 month follow-up ]
    • Intracranial, intraocular, intra-articular or retroperitoneal bleeding
    • Access site bleed requiring intervention/surgery
    • Hematoma ≥ 5 cm
    • Hemoglobin (Hgb) ≥4 g/dL without an overt source
    • Hgb ≥3 g/dL with an overt source
    • Operation for bleeding
    • Any blood transfusions
  • Stent thrombosis [ Time Frame: During follow-up ]
    • Definite or confirmed stent thrombosis: Angiographic confirmation of vessel occlusion or thrombus formation within, or adjacent to, the stented segment or proven stent thrombosis at autopsy.
    • Probable stent thrombosis: Unexplained death within 30 days or target vessel recurrent MI without angiographic confirmation.
    • Possible stent thrombosis: Unexplained death after 30 days.
  • Angiographic endpoint: TIMI flow [ Time Frame: At 9 months follow-up ]
  • Angiographic endpoint: late lumen loss [ Time Frame: At 9 months follow-up ]
  • Angiographic endpoint: minimal lumen diameter [ Time Frame: At 9 months follow-up ]
  • Angiographic endpoint: diameter stenosis [ Time Frame: At 9 months follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction
Official Title  ICMJE Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.
Brief Summary

Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result.

Objective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).

Detailed Description

Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result.

Objective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).

Study design: This is a prospective, single center, non-inferiority, randomized controlled trial.

Study population: All patients presenting with STEMI and suitable for PPCI.

Intervention: PPCI will be performed according to current guidelines. After thrombus aspiration and pre-dilatation, randomization between a DCB only strategy (with bail-out stenting if indicated) and DES will be done by 1:1 ratio. Concomitant medication will be administered according current standards. Control coronary angiography, including measurement of the fractional flow reserve (FFR) of the treated lesion(s), will be performed after 9 months.

Main study parameters/endpoints: The main study parameter is the fractional flow reserve at 9 months follow-up. Secondary study parameters include cardiac death, recurrent myocardial infarction in the target vessel area and ischemia driven target lesion revascularisation at 9 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Acute Myocardial Infarction
Intervention  ICMJE Procedure: Treatment according arm
Study Arms  ICMJE
  • Active Comparator: Drug-eluting stent
    Treatment of infarct related laesion with a drug-eluting stent
    Intervention: Procedure: Treatment according arm
  • Experimental: Drug-coated balloon
    After treatment of the infarct related artery with a drug-coated ballon, an additional BMS is advised to be used in case of residual stenosis > 50% or coronary artery dissection type > B.
    Intervention: Procedure: Treatment according arm
Publications *

*   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
Estimated Enrollment  ICMJE
 (submitted: August 15, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute myocardial infarction eligible for primary PCI:
  • > 20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ECG or echocardiography)
  • Reperfusion is expected to be feasible within 12 hours after onset of complaints
  • Infarct related artery eligible for PPCI and:
  • De novo lesion in a native coronary artery
  • Reference-vessel diameter ≥ 2.5mm and ≤ 4mm
  • Without severe calcification
  • Without diameter stenosis of >50% (by visual assessment) after thrombus aspiration and pre-dilatation.

The protocol requires visualization, thrombus aspiration and pre-dilatation of the culprit lesion before inclusion.

Exclusion Criteria:

  • Age < 18 years and > 75 years
  • History of myocardial infarction
  • Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor.
  • Participation in another clinical study, interfering with this protocol
  • Uncertain neurological outcome e.g. resuscitation
  • Intubation/ventilation
  • Cardiogenic shock prior to randomization
  • Known intracranial disease (mass, aneurysm, AVM, hemorrhagic CVA, ischemic CVA/TIA < 6 months prior to inclusion or ischemic CVA with permanent neurological deficit)
  • Gastro-intestinal / urinary tract bleeding < 2 months prior to inclusion
  • Refusal to receive blood transfusion
  • Planned major surgery within 6 weeks
  • Stent implantation < 1 month prior to inclusion
  • Expected mortality from any cause within the next 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219802
Other Study ID Numbers  ICMJE NL48495.100.14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis
Study Sponsor  ICMJE Onze Lieve Vrouwe Gasthuis
Collaborators  ICMJE
  • Biotronik SE & Co. KG
  • Volcano Corporation
Investigators  ICMJE
Principal Investigator: R. J. van der Schaaf, MD, PhD OLVG
PRS Account Onze Lieve Vrouwe Gasthuis
Verification Date August 2014

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