Coronary Artery DiseaseREVELATIONNCT02219802
Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction
A study testing Treatment according arm in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Acute Myocardial Infarction
- What is being tested?
- Treatment according arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
R. J. van der Schaaf, MD, PhD
About this study
Official title: Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.
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).
Read the 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.
- Being tested
- Treatment according arm
- Keywords
- Coronary artery disease, Acute myocardial infarction, Drug-coated balloon, Drug-eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment according armProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting stent | Active comparator | Treatment of infarct related laesion with a drug-eluting stent Receives: Procedure: Treatment according arm |
| Drug-coated balloon | Experimental | 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. Receives: Procedure: Treatment according arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional flow reserve (FFR)
Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.
Measured: At 9 months follow-up
Secondary outcomes (9)
Major adverse cardiac event (MACE)
- Cardiac death (ARC); defined as any death in which a cardiac cause cannot be excluded.
- Recurrent MI in the target vessel area.
- 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).
Measured: In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up.
Angiographic endpoint: iFR
Measured: At 9 months follow-up.
ST-segment resolution
ST-segment resolution post-initial procedure at 90 minutes, defined as the ST-segment deviation resolution in only the single lead showing maximum deviation.
Measured: 90 minutes after initial procedure
Non-coronary artery bypass grafting major bleeding
- 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
Measured: At 1 month follow-up
Stent thrombosis
- 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.
Measured: During follow-up
Angiographic endpoint: TIMI flow
Measured: At 9 months follow-up
Angiographic endpoint: late lumen loss
Measured: At 9 months follow-up
Angiographic endpoint: minimal lumen diameter
Measured: At 9 months follow-up
Angiographic endpoint: diameter stenosis
Measured: At 9 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG, Volcano Corporation
- Responsible party
- Principal investigator, J.P.R. Herrman, Onze Lieve Vrouwe Gasthuis
- Investigators
- R. J. van der Schaaf, MD, PhD, Principal investigator, OLVG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219802
- Sponsor's protocol ID
- NL48495.100.14
- Acronym
- REVELATION
- Status last verified
- Aug 2014
- First submitted
- 30 Jun 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
PubMed 12517460Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901.
PubMed 10547403Stone GW, Grines CL, Browne KF, Marco J, Rothbaum D, O'Keefe J, Hartzler GO, Overlie P, Donohue B, Chelliah N, et al. Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) trail. J Am Coll Cardiol. 1995 Feb;25(2):370-7. doi: 10.1016/0735-1097(94)00367-y.
PubMed 7829790Zijlstra F, de Boer MJ, Hoorntje JC, Reiffers S, Reiber JH, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction. N Engl J Med. 1993 Mar 11;328(10):680-4. doi: 10.1056/NEJM199303113281002.
PubMed 8433726Mintz GS. Remodeling and Restenosis: Observations from Serial Intravascular Ultrasound Studies. Curr Interv Cardiol Rep. 2000 Nov;2(4):316-325.
PubMed 11096682Zhu MM, Feit A, Chadow H, Alam M, Kwan T, Clark LT. Primary stent implantation compared with primary balloon angioplasty for acute myocardial infarction: a meta-analysis of randomized clinical trials. Am J Cardiol. 2001 Aug 1;88(3):297-301. doi: 10.1016/s0002-9149(01)01645-9. No abstract available.
PubMed 11472712De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A, Chiariello M, Marino P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol. 2008 May 7;126(1):37-44. doi: 10.1016/j.ijcard.2007.03.112. Epub 2007 Jun 4.
PubMed 17544528Suryapranata H, De Luca G, van 't Hof AW, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosselink AT, Zijlstra F, de Boer MJ. Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients. Heart. 2005 May;91(5):641-5. doi: 10.1136/hrt.2004.056705.
PubMed 15831652Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.
PubMed 16971717Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvanne M, Suttorp MJ, Violini R, Schomig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. doi: 10.1093/eurheartj/ehm402. Epub 2007 Sep 27.
PubMed 17901079De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C, Valgimigli M, Di Lorenzo E, Dirksen MT, Spaulding C, Pittl U, Violini R, Percoco G, Marino P. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol. 2009 Apr 3;133(2):213-22. doi: 10.1016/j.ijcard.2007.12.040. Epub 2008 Apr 3.
PubMed 18394731Degertekin M, Serruys PW, Tanabe K, Lee CH, Sousa JE, Colombo A, Morice MC, Ligthart JM, de Feyter PJ. Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation. 2003 Dec 2;108(22):2747-50. doi: 10.1161/01.CIR.0000103666.25660.77. Epub 2003 Nov 24.
PubMed 14638542McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.
PubMed 15500897Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.
PubMed 18725485Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv. 2011 Jan;4(1):24-9. doi: 10.1016/j.jcin.2010.11.003.
PubMed 21251625
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02219802
- Acronym / sponsor ID
- REVELATION / NL48495.100.14
- Keywords
- Coronary artery disease, Acute myocardial infarction, Drug-coated balloon, Drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG, Volcano Corporation
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting stent | Active comparator | Procedure: Treatment according armTreatment of infarct related laesion with a drug-eluting stent |
| Drug-coated balloon | Experimental | Procedure: Treatment according armAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment according arm | Procedure or surgery | Drug-coated balloon, Drug-eluting stent |
Primary outcome
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.
9 secondary outcomes
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.
Angiographic endpoint: iFR
Time frame: At 9 months follow-up.
ST-segment resolution
Time frame: 90 minutes after initial procedure
Non-coronary artery bypass grafting major bleeding
Time frame: At 1 month follow-up
Stent thrombosis
Time frame: During follow-up
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Background: PubMed 12517460Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
- Background: PubMed 10547403Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901.
- Background: PubMed 7829790Stone GW, Grines CL, Browne KF, Marco J, Rothbaum D, O'Keefe J, Hartzler GO, Overlie P, Donohue B, Chelliah N, et al. Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) trail. J Am Coll Cardiol. 1995 Feb;25(2):370-7. doi: 10.1016/0735-1097(94)00367-y.
- Background: PubMed 8433726Zijlstra F, de Boer MJ, Hoorntje JC, Reiffers S, Reiber JH, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction. N Engl J Med. 1993 Mar 11;328(10):680-4. doi: 10.1056/NEJM199303113281002.
- Background: PubMed 11096682Mintz GS. Remodeling and Restenosis: Observations from Serial Intravascular Ultrasound Studies. Curr Interv Cardiol Rep. 2000 Nov;2(4):316-325.
- Background: PubMed 11472712Zhu MM, Feit A, Chadow H, Alam M, Kwan T, Clark LT. Primary stent implantation compared with primary balloon angioplasty for acute myocardial infarction: a meta-analysis of randomized clinical trials. Am J Cardiol. 2001 Aug 1;88(3):297-301. doi: 10.1016/s0002-9149(01)01645-9. No abstract available.
- Background: PubMed 17544528De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A, Chiariello M, Marino P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol. 2008 May 7;126(1):37-44. doi: 10.1016/j.ijcard.2007.03.112. Epub 2007 Jun 4.
- Background: PubMed 15831652Suryapranata H, De Luca G, van 't Hof AW, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosselink AT, Zijlstra F, de Boer MJ. Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients. Heart. 2005 May;91(5):641-5. doi: 10.1136/hrt.2004.056705.
- Background: PubMed 16971717Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.
- Background: PubMed 17901079Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvanne M, Suttorp MJ, Violini R, Schomig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. doi: 10.1093/eurheartj/ehm402. Epub 2007 Sep 27.
- Background: PubMed 18394731De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C, Valgimigli M, Di Lorenzo E, Dirksen MT, Spaulding C, Pittl U, Violini R, Percoco G, Marino P. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol. 2009 Apr 3;133(2):213-22. doi: 10.1016/j.ijcard.2007.12.040. Epub 2008 Apr 3.
- Background: PubMed 14638542Degertekin M, Serruys PW, Tanabe K, Lee CH, Sousa JE, Colombo A, Morice MC, Ligthart JM, de Feyter PJ. Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation. 2003 Dec 2;108(22):2747-50. doi: 10.1161/01.CIR.0000103666.25660.77. Epub 2003 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. J. van der Schaaf, MD, PhD principal investigator
OLVG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment according arm in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R. J. van der Schaaf, MD, PhD (+31-20-5992387, r.j.vanderschaaf@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional flow reserve (FFR) (time frame: At 9 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02219802, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.