Coronary Artery DiseasePhase 1/2TROFINCT01271361
Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients
A Phase 1/2 study testing primary PCI with thrombectomy and primary PCI without thrombectomy in people with Coronary Artery Disease and Myocardial Infarction, run by Terumo Europe N.V. at 5 sites in 4 countries.
Trial summary
The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, STEMI
- What is being tested?
- primary PCI with thrombectomy and primary PCI without thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Nov 2010to Dec 2012
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age.
- Patients with a ST-elevation Myocardial Infarction documented in an ambulance or in a Cathlab with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min and having an angiographical visible stenosis (>30%) or TIMI≤ II in de-novo, native, previously unstented vessel.
- The single vessel coronary artery disease.
- Signed Informed Consent.
- The patient understands and accepts clinical follow-up and OFDI controls.
- Patients residence is in the area covered by hospital. Angiographic
Show all 10Show fewer
- Vessel size should match available Nobori stent sizes (<4.0 mm, and >2.0 mm by visual assessment).
- Additional Inclusion criteria (applicable only for France)
- Patients residence is in the area covered by hospital.
- Patient is affiliated to social security or equivalent system.
Who cannot join
- Pregnancy and women of child bearing potential (less than 50 years of age).
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast material.
- Diameter Stenosis <30% in the target lesion.
- The multi-vessel coronary artery disease (DS>50%).
- Unprotected left main disease with a diameter stenosis of >30% by visual assessment.
- Distal vessel occlusion.
Show all 18Show fewer
- Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter.
- Fibrinolysis prior to PCI.
- Known thrombocytopaenia (PLT< 100,000/mm3).
- Contraindication to PCI, stenting, ASA, clopidogrel.
- Active bleeding or coagulopathy or patients at chronic anticoagulation therapy.
- Cardiogenic Shock.
- Significant comorbidities precluding clinical follow-up (as judged by investigators).
- Major planned surgery that requires discontinuation of dual antiplatelet therapy.
- Proximal RCA stenosis (>30%) if the infarct-related artery is mid-RCA or distal-RCA.
- People under judicial protection.
- A patient who has congenital heart disease, severe cardiac valve disorder and/or myocardial disease (excluding status post MI).
- Patient participating in other clinical research study.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Netherlands2 sites
Erasmus Medical Center
Rotterdam, 3000CA
Maastad Hospital
Rotterdam, 3015EA
About this study
Official title: Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study
The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.
Read the detailed description
Primary percutaneous coronary intervention has been well established as the treatment of choice for the majority of patients presenting with acute ST elevation myocardial infarction (STEMI). However primary PCI alone is unable to remove intracoronary thrombus and this often results in distal embolisation, no reflow which in turn leads to impaired myocardial perfusion. This can result in left ventricular dysfunction and subsequently increased mortality.
The use of thrombectomy devices during percutaneous coronary intervention in the setting of acute ST elevation myocardial infarction has been recently shown to improve epicardial, myocardial perfusion, angiographical TIMI flow, blush score, or result in less embolisation. Moreover thrombus aspiration or rheolysis has been shown to decrease cardiac death and repeat myocardial infarction.
It is estimated that late stent malapposition is more common after stenting in the course of primary PCI as compared with elective PCI, and may predispose to stent thrombosis. Late malapposition may be related to underdeployment of stents at the time of primary PCI, and this may be due in part to thrombus behind the stent, which subsequently resolves and leads to stent malapposition. Removal of thrombus before stenting potentially could lead to better stent expansion and less late malapposition.
On the other hand, the impact of thrombus on acute and chronic luminal dimension is still unclear in a setting of primary PCI. After stenting, such thrombus either I) protrude into the lumen through the mesh of metallic stent struts or II) is crushed between the vessel wall and stent. Theoretically, the protruded thrombus can hinder the intra-luminal flow immediately after stenting, while the resorption of crushed thrombus against vessel wall might result at long term in stent malaposition.
Due to the limited ability of the conventional angiography and the intravascular ultrasound (IVUS) to detect thrombus, these aspects have not been investigated.
Optical coherence tomography has recently been shown to be feasible and to provide valuable information in the setting of acute myocardial infarction. This imaging modality has been shown to be even more sensitive to detect intraluminal mass (i.e. thrombus) and offers unique possibilities of analysis of coronary intervention in acute myocardial infarction.
TERUMO OFDI is a novel optical imaging device that uses a scanning laser as light source which centre wavelength is around 1.3 μm with sweeping range over 100 nm. The echo-time delay and the amplitude of light reflected from the tissue microstructure at different depths are determined by processing the interference between the tissue sample and a fixed reference mirror.
Compared to the conventional OCT imaging devices, OFDI has a higher temporal frame rate (160 frames/sec), with a faster pullback speed of maximally up to 40 mm/s. The safety and performance of the device has been investigated in the First-in-man study enrolling 19 patients where both IVUS and OFDI were performed. In the study, OFDI was associated with no device-related adverse events, and with a good correlation with IVUS measurement.
We hypothesize that TERUMO Eliminate® thrombectomy device will reduce the thrombus burden in STEMI patients and this will result in less intraluminal material and larger flow area, measured with OFDI. This will be clinically translated in a better restoration of blood flow and reduce further damage of the myocardium.
In addition, a reduction of thrombus burden would eventually result in less stent malaposition at 6 months. Given the benefits of reducing thrombus burden in STEMI as described above, the study may have important implications on the prove of the effectiveness of the thrombectomy device and the use of this imaging modality to assess its efficacy. To best assess benefits of thrombus removal, a randomized controlled study was considered the most appropriate method.
- Conditions
- Coronary Artery Disease, Myocardial Infarction, STEMI
- Being tested
- primary PCI with thrombectomy, primary PCI without thrombectomy
- Keywords
- thrombus aspiration, Drug-Eluting Stent, optical frequency domain imaging (OFDI)
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary PCI with thrombectomyProcedure or surgery
Also called Eliminate thrombectomy device, Nobori Biolimus A9 drug-eluting stent
thrombectomy is performed before implantation of a drug eluting stent
primary PCI without thrombectomyProcedure or surgery
Also called Nobori Biolimus A9 drug-eluting stent
no thrombectomy is performed before the implantation of a drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| primary PCI with thrombectomy | Experimental | thrombectomy before implantation of drug eluting stent Receives: Procedure: primary PCI with thrombectomy |
| primary PCI without thrombectomy | Active comparator | implantation of a drug eluting stent without thrombectomy Receives: Procedure: primary PCI without thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimal flow area assessed by OFDI
Flow area is defined as: (Stent area + incomplete stent apposition area) - (intraluminal defect area attached to the wall + intraluminal defect area free from the wall)
Measured: at baseline procedure (post-stenting)
Secondary outcomes (17)
normalised minimal flow area
defined as the ratio of minimal flow divided by stent area at the site of the minimal flow area
Measured: at baseline procedure (post stenting)
mean flow area/volume
Measured: at baseline procedure (post stenting) and at 6 months
intraluminal defect area/volume
Measured: at baseline procedure (post stenting) and at 6 months
mean stent area/volume
Measured: at baseline procedure (post stenting) and at 6 months
percent of malapposed struts
Measured: at baseline procedure (post stenting) and at 6 months
incomplete stent apposition (ISA) area/volume
Measured: at baseline procedure (post stenting) and at 6 months
percent of struts with coverage
Measured: at 6 months
healing index
Measured: at 6 months
tissues prolapse area/volume
Measured: at 6 months
procedure success
attainment of <30% residual stenosis of the target lesion and no in-hospital target vessel failure
Measured: at baseline procedure
target vessel failure
defined as cardiac death, reinfarction in the territory of infarction related vessel (Q wave and non-Q wave), or clinically driven target vessel revascularization - and its individual components
Measured: at discharge, 1 month, 6 months and 12 months
all-cause mortality
Measured: at discharge, 1 month, 6 months and 12 months
cardiac death, non-cardiovascular death, vascular death
Measured: at discharge, 1 month, 6 months and 12 months
any myocardial (re)infarction
Measured: at discharge, 1 month, 6 months and 12 months
target vessel revascularization
Measured: at discharge, 1 month, 6 months and 12 months
stent thrombosis according to ARC definition
Measured: at discharge, 1 month, 6 months and 12 months
other serious adverse events (SAEs)
Measured: at discharge, 1 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick W Serruys, MD, Principal investigator, Erasmus Medical Center, Rotterdam, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271361
- Sponsor's protocol ID
- T114E4
- Acronym
- TROFI
- Status last verified
- Dec 2012
- First submitted
- 5 Jan 2011
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.
PubMed 19004841Zijlstra 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 10547403Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.
PubMed 10607811Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
PubMed 17692740Sianos G, Papafaklis MI, Vaina S, Daemen J, van Mieghem CA, Van Domburg RT, Michalis LK, de Jaegere P, Serruys PW. Rheolytic thrombectomy in patients with ST-elevation myocardial infarction and large thrombus burden: the Thoraxcenter experience. J Invasive Cardiol. 2006 Jul;18 Suppl C:3C-7C.
PubMed 16883024Haeck JD, Koch KT, Bilodeau L, Van der Schaaf RJ, Henriques JP, Vis MM, Baan J Jr, Van der Wal AC, Piek JJ, Tijssen JG, Krucoff MW, De Winter RJ. Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study. JACC Cardiovasc Interv. 2009 Oct;2(10):934-43. doi: 10.1016/j.jcin.2009.07.013.
PubMed 19850252Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, Suzuki T, Yamashita T, Takizawa A, Misumi K, Hashimoto H, Isshiki T; VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):424-31. doi: 10.1016/j.jcin.2008.06.004.
PubMed 19463340Vlaar PJ, Svilaas T, Vogelzang M, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan E, Suurmeijer AJ, Zijlstra F. A comparison of 2 thrombus aspiration devices with histopathological analysis of retrieved material in patients presenting with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2008 Jun;1(3):258-64. doi: 10.1016/j.jcin.2008.03.014.
PubMed 19463309Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017.
PubMed 19161878Sardella G, Mancone M, Nguyen BL, De Luca L, Di Roma A, Colantonio R, Petrolini A, Conti G, Fedele F. The effect of thrombectomy on myocardial blush in primary angioplasty: the Randomized Evaluation of Thrombus Aspiration by two thrombectomy devices in acute Myocardial Infarction (RETAMI) trial. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):84-91. doi: 10.1002/ccd.21312.
PubMed 17985382Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalo G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006 Oct 17;48(8):1552-9. doi: 10.1016/j.jacc.2006.03.068. Epub 2006 Sep 26.
PubMed 17045887Svilaas T, van der Horst IC, Zijlstra F. Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design. Am Heart J. 2006 Mar;151(3):597.e1-597.e7. doi: 10.1016/j.ahj.2005.11.010.
PubMed 16504620Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 Jul 19;46(2):371-6. doi: 10.1016/j.jacc.2005.04.057.
PubMed 16022970De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F. Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. Eur Heart J. 2008 Dec;29(24):3002-10. doi: 10.1093/eurheartj/ehn389. Epub 2008 Sep 5.
PubMed 18775918Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, Lefevre T, Carrie D, Bartorelli A, Montalescot G, Parikh K. Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention. 2008 Aug;4(2):222-8. doi: 10.4244/eijv4i2a40.
PubMed 19110787
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study
- ClinicalTrials.gov ID
- NCT01271361
- Acronym / sponsor ID
- TROFI / T114E4
- Conditions
- Coronary Artery Disease, Myocardial Infarction, STEMI
- Keywords
- thrombus aspiration, Drug-Eluting Stent, optical frequency domain imaging (OFDI)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Jan 2011 (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.
The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.
Detailed description
Primary percutaneous coronary intervention has been well established as the treatment of choice for the majority of patients presenting with acute ST elevation myocardial infarction (STEMI). However primary PCI alone is unable to remove intracoronary thrombus and this often results in distal embolisation, no reflow which in turn leads to impaired myocardial perfusion. This can result in left ventricular dysfunction and subsequently increased mortality.
The use of thrombectomy devices during percutaneous coronary intervention in the setting of acute ST elevation myocardial infarction has been recently shown to improve epicardial, myocardial perfusion, angiographical TIMI flow, blush score, or result in less embolisation. Moreover thrombus aspiration or rheolysis has been shown to decrease cardiac death and repeat myocardial infarction.
It is estimated that late stent malapposition is more common after stenting in the course of primary PCI as compared with elective PCI, and may predispose to stent thrombosis. Late malapposition may be related to underdeployment of stents at the time of primary PCI, and this may be due in part to thrombus behind the stent, which subsequently resolves and leads to stent malapposition. Removal of thrombus before stenting potentially could lead to better stent expansion and less late malapposition.
On the other hand, the impact of thrombus on acute and chronic luminal dimension is still unclear in a setting of primary PCI. After stenting, such thrombus either I) protrude into the lumen through the mesh of metallic stent struts or II) is crushed between the vessel wall and stent. Theoretically, the protruded thrombus can hinder the intra-luminal flow immediately after stenting, while the resorption of crushed thrombus against vessel wall might result at long term in stent malaposition.
Due to the limited ability of the conventional angiography and the intravascular ultrasound (IVUS) to detect thrombus, these aspects have not been investigated.
Optical coherence tomography has recently been shown to be feasible and to provide valuable information in the setting of acute myocardial infarction. This imaging modality has been shown to be even more sensitive to detect intraluminal mass (i.e. thrombus) and offers unique possibilities of analysis of coronary intervention in acute myocardial infarction.
TERUMO OFDI is a novel optical imaging device that uses a scanning laser as light source which centre wavelength is around 1.3 μm with sweeping range over 100 nm. The echo-time delay and the amplitude of light reflected from the tissue microstructure at different depths are determined by processing the interference between the tissue sample and a fixed reference mirror.
Compared to the conventional OCT imaging devices, OFDI has a higher temporal frame rate (160 frames/sec), with a faster pullback speed of maximally up to 40 mm/s. The safety and performance of the device has been investigated in the First-in-man study enrolling 19 patients where both IVUS and OFDI were performed. In the study, OFDI was associated with no device-related adverse events, and with a good correlation with IVUS measurement.
We hypothesize that TERUMO Eliminate® thrombectomy device will reduce the thrombus burden in STEMI patients and this will result in less intraluminal material and larger flow area, measured with OFDI. This will be clinically translated in a better restoration of blood flow and reduce further damage of the myocardium.
In addition, a reduction of thrombus burden would eventually result in less stent malaposition at 6 months. Given the benefits of reducing thrombus burden in STEMI as described above, the study may have important implications on the prove of the effectiveness of the thrombectomy device and the use of this imaging modality to assess its efficacy. To best assess benefits of thrombus removal, a randomized controlled study was considered the most appropriate method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary PCI with thrombectomy | Experimental | Procedure: primary PCI with thrombectomythrombectomy before implantation of drug eluting stent |
| primary PCI without thrombectomy | Active comparator | Procedure: primary PCI without thrombectomyimplantation of a drug eluting stent without thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is at least 18 years of age.
- Patients with a ST-elevation Myocardial Infarction documented in an ambulance or in a Cathlab with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min and having an angiographical visible stenosis (>30%) or TIMI≤ II in de-novo, native, previously unstented vessel.
- The single vessel coronary artery disease.
- Signed Informed Consent.
- The patient understands and accepts clinical follow-up and OFDI controls.
Key exclusion criteria (18 listed)
- Pregnancy and women of child bearing potential (less than 50 years of age).
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast material.
- Diameter Stenosis <30% in the target lesion.
- The multi-vessel coronary artery disease (DS>50%).
- Unprotected left main disease with a diameter stenosis of >30% by visual assessment.
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 |
|---|---|---|
| primary PCI with thrombectomyAlso: Eliminate thrombectomy device, Nobori Biolimus A9 drug-eluting stentthrombectomy is performed before implantation of a drug eluting stent | Procedure or surgery | primary PCI with thrombectomy |
| primary PCI without thrombectomyAlso: Nobori Biolimus A9 drug-eluting stentno thrombectomy is performed before the implantation of a drug eluting stent | Procedure or surgery | primary PCI without thrombectomy |
Primary outcome
minimal flow area assessed by OFDI
Time frame: at baseline procedure (post-stenting)
Flow area is defined as: (Stent area + incomplete stent apposition area) - (intraluminal defect area attached to the wall + intraluminal defect area free from the wall)
17 secondary outcomes
normalised minimal flow area
Time frame: at baseline procedure (post stenting)
mean flow area/volume
Time frame: at baseline procedure (post stenting) and at 6 months
intraluminal defect area/volume
Time frame: at baseline procedure (post stenting) and at 6 months
mean stent area/volume
Time frame: at baseline procedure (post stenting) and at 6 months
percent of malapposed struts
Time frame: at baseline procedure (post stenting) and at 6 months
incomplete stent apposition (ISA) area/volume
Time frame: at baseline procedure (post stenting) and at 6 months
percent of struts with coverage
Time frame: at 6 months
healing index
Time frame: at 6 months
tissues prolapse area/volume
Time frame: at 6 months
procedure success
Time frame: at baseline procedure
target vessel failure
Time frame: at discharge, 1 month, 6 months and 12 months
all-cause mortality
Time frame: at discharge, 1 month, 6 months and 12 months
cardiac death, non-cardiovascular death, vascular death
Time frame: at discharge, 1 month, 6 months and 12 months
any myocardial (re)infarction
Time frame: at discharge, 1 month, 6 months and 12 months
target vessel revascularization
Time frame: at discharge, 1 month, 6 months and 12 months
stent thrombosis according to ARC definition
Time frame: at discharge, 1 month, 6 months and 12 months
other serious adverse events (SAEs)
Time frame: at discharge, 1 month, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
- Background: PubMed 19004841Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.
- 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 10607811Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56. doi: 10.1056/NEJM199912233412601.
- Background: PubMed 17692740Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
- Background: PubMed 16883024Sianos G, Papafaklis MI, Vaina S, Daemen J, van Mieghem CA, Van Domburg RT, Michalis LK, de Jaegere P, Serruys PW. Rheolytic thrombectomy in patients with ST-elevation myocardial infarction and large thrombus burden: the Thoraxcenter experience. J Invasive Cardiol. 2006 Jul;18 Suppl C:3C-7C.
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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.
Patrick W Serruys, MD principal investigator
Erasmus Medical Center, Rotterdam, Netherlands
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing primary PCI with thrombectomy and primary PCI without thrombectomy in people with Coronary Artery Disease and Myocardial Infarction, run by Terumo Europe N.V. at 5 sites in 4 countries.
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 10 inclusion and 18 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: finished, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Denmark, France, Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minimal flow area assessed by OFDI (time frame: at baseline procedure (post-stenting)). 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 NCT01271361, which also lists 25 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 7 Dec 2012.