Coronary Artery DiseaseORBID-OANCT03058510
Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion
An observational study of Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery disease. The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Frequency domain optical coherence tomography
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2016to 13 Oct 2017
- Phase
- Observational
- 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
Study population: Thirty consecutive patients with calcified lesions requiring PCI of main vessel with drug eluting stent implantation for the treatment of stable CAD will be included in the study.
Who may be able to join
- All patients over 18 years of age presenting with stable coronary artery disease.
- Angiographic lesion with severe calcification with or without side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited
Who cannot join
- Patients with ostial left main artery lesions or ostial right coronary artery lesions
- Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Known allergy to acetylsalicylic acid or clopidogrel.
- Planned surgery within 12 months.
- History of bleeding diathesis
- Major surgery within 15 days
- Life expectancy < 12 months.
- Patients with kidney dysfunction (CrCl<30)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
New York, New York, 10029
About this study
ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery disease.
The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain optical coherence tomography (FD-OCT).
Read the detailed description
Coronary artery bifurcation lesion is a common lesion subset in PCI accounting for 15-20% of the total number of interventions (1). Treatment of coronary artery bifurcation lesions represents a challenging area in interventional cardiology (2). When compared with non-bifurcation interventions, bifurcation interventions have a lower rate of procedural success, higher procedural costs, longer hospitalization and a higher clinical and angiographic restenosis (3). Factors contributing to this adverse outcome include limitations of angiography in assessment of side-branch (SB) disease severity and the lack of established angiographic predictors of SB patency and lumen compromise. Better understanding of the underlying plaque morphology and plaque composition may facilitate more effective treatment of bifurcation lesions.
Heavy calcification within coronary atherosclerotic plaque adversely influences both clinical and procedural success after percutaneous coronary interventions (PCI) (4,5). The use of drug-eluting stent (DES) in calcified lesions poses special challenges. Atherectomy can facilitate successful stent delivery and expansion in calcified lesions. Orbital atherectomy (OA) is the newly FDA approved device for treatment of severely calcified coronary lesions which works on the principle of elliptical burr movement. The ORBIT I and II clinical trials evaluated the safety of OA in de novo calcified coronary lesions and demonstrated that complication rate was comparable to historical controls of rotational atherectomy (6).
Intravascular imaging has provided new understanding of mechanisms associated with SB compromise following bifurcation PCI (7-9). Plaque shift has been traditionally considered as the principal mechanism for side-branch compromise after main vessel intervention (9), however recent intravascular imaging studies have provided new insights by suggesting carina shift as a major mechanism implicated in side-branch closure (7). Intravascular ultrasound (IVUS) has been used for guidance in bifurcation lesions, aiding the visualization of plaque morphology at the main vessel and the side-branches and helping the selection of stent size and length as well as the selection of stenting strategy. However, due to the low spatial resolution of IVUS, all attempts for three-dimensional visualization have only focused on visualization of the luminal contour and not on the vessel morphology or the vessel-stent interaction. Optical coherence tomography (OCT) has ~10 times higher resolution than IVUS which allows precise evaluation of the microstructure of the vessel wall including lipid pool, fibrous cap, calcification, and thrombus (10). In addition, it provides immediate automated measurements for lumen dimensions before the treatment and precise evaluation of strut apposition and stent expansion after stenting, which is of particular interest in bifurcation PCI, since it's been associated with a higher number of malapposed stent struts and more frequent stent underexpansion leading to higher incidence of stent thrombosis and restenosis.
OCT has been shown to constitute a valuable tool for PCI guidance and also the utility of three-dimensional (3D) renderings for assessing the mechanism of side-branch compromise following intervention in bifurcation lesions. (11,12). The recent development of OCT with online 3D reconstruction allows the operator to obtain a 3D visualization of the lesion and may provide a unique tool for guidance during complex bifurcation PCI and potentially improve stenting results (12). 3D OCT has been used to visualize jailed side branches after implantation of bioresorbable scaffolds in the main branch and develop a new classification system based on the number of SB compartments (13). In addition, its potential clinical application in guiding the rewiring of the distal compartment of the SB ostium (jailed with stent struts after MB stenting) to minimize the risk of floating struts was demonstrated.
The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain optical coherence tomography (FD-OCT). Thirty consecutive patients with calcified lesions requiring PCI of main vessel with drug eluting stent implantation for the treatment of stable CAD will be included in the study. All potential subjects will sign a separate Mount Sinai surgical/procedure informed consent for their Cardiac Catheterization procedure on the day of their hospital visit.
Patients will undergo coronary angiogram. OCT will be performed to analyze plaque morphology, the extent and location of calcification, side branch size, angle, and ostial involvement. Patients will undergo PCI with stent implantation according to current standards of care. Lesion preparation including lesion pre-dilation, and use of atherectomy and protection devices will be performed at the operator's discretion, followed by MV stenting. The operator will also decide on length and size of the implanted stent. Procedural optimization, such as post-dilation or additional stent implantation will be performed based only on the angiographic findings, according to the discretion of the operator. Coronary angiogram and another OCT pullback will be performed after PCI.
- Conditions
- Coronary Artery Disease
- Being tested
- Frequency domain optical coherence tomography
- Keywords
- bifurcation lesion, atherectomy, calcification, stent
- Medical subject headings
- Coronary Artery Disease, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency domain optical coherence tomographyProcedure or surgery
Also called coronary angiogram, FD OCT
OCT is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels
| Study group | Role | What they receive |
|---|---|---|
| Stable CAD Patients | Stable CAD patients with calcified bifurcation lesion Receives: Procedure: Frequency domain optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Incidence of placing a stent with less than 50% residual stenosis
Measured: Day 1
Secondary outcomes (1)
Acute angiographic complications
Incidence of acute angiographic complications
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start17 Jan 2016
- Primary completion13 Oct 2017
- Study completion13 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Annapoorna Kini, MD MRCP FACC, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058510
- Sponsor's protocol ID
- GCO 16-1561
- Acronym
- ORBID-OA
- Status last verified
- Dec 2017
- First submitted
- 16 Feb 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Suwaidi J, Berger PB, Rihal CS, Garratt KN, Bell MR, Ting HH, Bresnahan JF, Grill DE, Holmes DR Jr. Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions. J Am Coll Cardiol. 2000 Mar 15;35(4):929-36. doi: 10.1016/s0735-1097(99)00648-8.
PubMed 10732890Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.
PubMed 16226167Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.
PubMed 19962049Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
PubMed 26811276Moussa I, Ellis SG, Jones M, Kereiakes DJ, McMartin D, Rutherford B, Mehran R, Collins M, Leon MB, Popma JJ, Russell ME, Stone GW. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol. 2005 Nov 1;96(9):1242-7. doi: 10.1016/j.amjcard.2005.06.064. Epub 2005 Sep 15.
PubMed 16253590Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5.
PubMed 23460596Karanasos A, Tu S, van der Heide E, Reiber JH, Regar E. Carina shift as a mechanism for side-branch compromise following main vessel intervention: insights from three-dimensional optical coherence tomography. Cardiovasc Diagn Ther. 2012 Jun;2(2):173-7. doi: 10.3978/j.issn.2223-3652.2012.04.01. No abstract available.
PubMed 24282711Suarez de Lezo J, Medina A, Martin P, Novoa J, Suarez de Lezo J, Pan M, Caballero E, Melian F, Mazuelos F, Quevedo V. Predictors of ostial side branch damage during provisional stenting of coronary bifurcation lesions not involving the side branch origin: an ultrasonographic study. EuroIntervention. 2012 Feb;7(10):1147-54. doi: 10.4244/EIJV7I10A185.
PubMed 22030298Farooq V, Serruys PW, Heo JH, Gogas BD, Okamura T, Gomez-Lara J, Brugaletta S, Garcia-Garcia HM, van Geuns RJ. New insights into the coronary artery bifurcation hypothesis-generating concepts utilizing 3-dimensional optical frequency domain imaging. JACC Cardiovasc Interv. 2011 Aug;4(8):921-31. doi: 10.1016/j.jcin.2011.06.004.
PubMed 21851908Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079.
PubMed 22421299Di Mario C, Iakovou I, van der Giessen WJ, Foin N, Adrianssens T, Tyczynski P, Ghilencea L, Viceconte N, Lindsay AC. Optical coherence tomography for guidance in bifurcation lesion treatment. EuroIntervention. 2010 Dec;6 Suppl J:J99-J106. doi: 10.4244/EIJV6SUPJA16.
PubMed 21930500Karanasos A, Tu S, van der Linden M, van Weenen S, Ligthart J, Regar E. Online 3-dimensional rendering of optical coherence tomography images for the assessment of bifurcation intervention. Can J Cardiol. 2012 Nov-Dec;28(6):759.e1-3. doi: 10.1016/j.cjca.2012.04.017. Epub 2012 Jul 3.
PubMed 22763361
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion
- ClinicalTrials.gov ID
- NCT03058510
- Acronym / sponsor ID
- ORBID-OA / GCO 16-1561
- Conditions
- Coronary Artery Disease
- Keywords
- bifurcation lesion, atherectomy, calcification, stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 17 Jan 2016 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 13 Oct 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery disease.
The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain optical coherence tomography (FD-OCT).
Detailed description
Coronary artery bifurcation lesion is a common lesion subset in PCI accounting for 15-20% of the total number of interventions (1). Treatment of coronary artery bifurcation lesions represents a challenging area in interventional cardiology (2). When compared with non-bifurcation interventions, bifurcation interventions have a lower rate of procedural success, higher procedural costs, longer hospitalization and a higher clinical and angiographic restenosis (3). Factors contributing to this adverse outcome include limitations of angiography in assessment of side-branch (SB) disease severity and the lack of established angiographic predictors of SB patency and lumen compromise. Better understanding of the underlying plaque morphology and plaque composition may facilitate more effective treatment of bifurcation lesions.
Heavy calcification within coronary atherosclerotic plaque adversely influences both clinical and procedural success after percutaneous coronary interventions (PCI) (4,5). The use of drug-eluting stent (DES) in calcified lesions poses special challenges. Atherectomy can facilitate successful stent delivery and expansion in calcified lesions. Orbital atherectomy (OA) is the newly FDA approved device for treatment of severely calcified coronary lesions which works on the principle of elliptical burr movement. The ORBIT I and II clinical trials evaluated the safety of OA in de novo calcified coronary lesions and demonstrated that complication rate was comparable to historical controls of rotational atherectomy (6).
Intravascular imaging has provided new understanding of mechanisms associated with SB compromise following bifurcation PCI (7-9). Plaque shift has been traditionally considered as the principal mechanism for side-branch compromise after main vessel intervention (9), however recent intravascular imaging studies have provided new insights by suggesting carina shift as a major mechanism implicated in side-branch closure (7). Intravascular ultrasound (IVUS) has been used for guidance in bifurcation lesions, aiding the visualization of plaque morphology at the main vessel and the side-branches and helping the selection of stent size and length as well as the selection of stenting strategy. However, due to the low spatial resolution of IVUS, all attempts for three-dimensional visualization have only focused on visualization of the luminal contour and not on the vessel morphology or the vessel-stent interaction. Optical coherence tomography (OCT) has ~10 times higher resolution than IVUS which allows precise evaluation of the microstructure of the vessel wall including lipid pool, fibrous cap, calcification, and thrombus (10). In addition, it provides immediate automated measurements for lumen dimensions before the treatment and precise evaluation of strut apposition and stent expansion after stenting, which is of particular interest in bifurcation PCI, since it's been associated with a higher number of malapposed stent struts and more frequent stent underexpansion leading to higher incidence of stent thrombosis and restenosis.
OCT has been shown to constitute a valuable tool for PCI guidance and also the utility of three-dimensional (3D) renderings for assessing the mechanism of side-branch compromise following intervention in bifurcation lesions. (11,12). The recent development of OCT with online 3D reconstruction allows the operator to obtain a 3D visualization of the lesion and may provide a unique tool for guidance during complex bifurcation PCI and potentially improve stenting results (12). 3D OCT has been used to visualize jailed side branches after implantation of bioresorbable scaffolds in the main branch and develop a new classification system based on the number of SB compartments (13). In addition, its potential clinical application in guiding the rewiring of the distal compartment of the SB ostium (jailed with stent struts after MB stenting) to minimize the risk of floating struts was demonstrated.
The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain optical coherence tomography (FD-OCT). Thirty consecutive patients with calcified lesions requiring PCI of main vessel with drug eluting stent implantation for the treatment of stable CAD will be included in the study. All potential subjects will sign a separate Mount Sinai surgical/procedure informed consent for their Cardiac Catheterization procedure on the day of their hospital visit.
Patients will undergo coronary angiogram. OCT will be performed to analyze plaque morphology, the extent and location of calcification, side branch size, angle, and ostial involvement. Patients will undergo PCI with stent implantation according to current standards of care. Lesion preparation including lesion pre-dilation, and use of atherectomy and protection devices will be performed at the operator's discretion, followed by MV stenting. The operator will also decide on length and size of the implanted stent. Procedural optimization, such as post-dilation or additional stent implantation will be performed based only on the angiographic findings, according to the discretion of the operator. Coronary angiogram and another OCT pullback will be performed after PCI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable CAD Patients | – | Procedure: Frequency domain optical coherence tomographyStable CAD patients with calcified bifurcation lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty consecutive patients with calcified lesions requiring PCI of main vessel with drug eluting stent implantation for the treatment of stable CAD will be included in the study.
Key inclusion criteria (2 listed)
- All patients over 18 years of age presenting with stable coronary artery disease.
- Angiographic lesion with severe calcification with or without side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited
Key exclusion criteria (8 listed)
- Patients with ostial left main artery lesions or ostial right coronary artery lesions
- Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Known allergy to acetylsalicylic acid or clopidogrel.
- Planned surgery within 12 months.
- History of bleeding diathesis
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 |
|---|---|---|
| Frequency domain optical coherence tomographyAlso: coronary angiogram, FD OCTOCT is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels | Procedure or surgery | Stable CAD Patients |
Primary outcome
Procedural success
Time frame: Day 1
Incidence of placing a stent with less than 50% residual stenosis
1 secondary outcome
Acute angiographic complications
Time frame: Day 1
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 8 Dec 2017.
- Background: PubMed 10732890Al Suwaidi J, Berger PB, Rihal CS, Garratt KN, Bell MR, Ting HH, Bresnahan JF, Grill DE, Holmes DR Jr. Immediate and long-term outcome of intracoronary stent implantation for true bifurcation lesions. J Am Coll Cardiol. 2000 Mar 15;35(4):929-36. doi: 10.1016/s0735-1097(99)00648-8.
- Background: PubMed 16226167Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.
- Background: PubMed 19962049Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.
- Background: PubMed 26811276Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
- Background: PubMed 16253590Moussa I, Ellis SG, Jones M, Kereiakes DJ, McMartin D, Rutherford B, Mehran R, Collins M, Leon MB, Popma JJ, Russell ME, Stone GW. Impact of coronary culprit lesion calcium in patients undergoing paclitaxel-eluting stent implantation (a TAXUS-IV sub study). Am J Cardiol. 2005 Nov 1;96(9):1242-7. doi: 10.1016/j.amjcard.2005.06.064. Epub 2005 Sep 15.
- Background: PubMed 23460596Parikh K, Chandra P, Choksi N, Khanna P, Chambers J. Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5.
- Background: PubMed 24282711Karanasos A, Tu S, van der Heide E, Reiber JH, Regar E. Carina shift as a mechanism for side-branch compromise following main vessel intervention: insights from three-dimensional optical coherence tomography. Cardiovasc Diagn Ther. 2012 Jun;2(2):173-7. doi: 10.3978/j.issn.2223-3652.2012.04.01. No abstract available.
- Background: PubMed 22030298Suarez de Lezo J, Medina A, Martin P, Novoa J, Suarez de Lezo J, Pan M, Caballero E, Melian F, Mazuelos F, Quevedo V. Predictors of ostial side branch damage during provisional stenting of coronary bifurcation lesions not involving the side branch origin: an ultrasonographic study. EuroIntervention. 2012 Feb;7(10):1147-54. doi: 10.4244/EIJV7I10A185.
- Background: PubMed 21851908Farooq V, Serruys PW, Heo JH, Gogas BD, Okamura T, Gomez-Lara J, Brugaletta S, Garcia-Garcia HM, van Geuns RJ. New insights into the coronary artery bifurcation hypothesis-generating concepts utilizing 3-dimensional optical frequency domain imaging. JACC Cardiovasc Interv. 2011 Aug;4(8):921-31. doi: 10.1016/j.jcin.2011.06.004.
- Background: PubMed 22421299Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, Falk E, Feldman MD, Fitzgerald P, Garcia-Garcia HM, Gonzalo N, Granada JF, Guagliumi G, Holm NR, Honda Y, Ikeno F, Kawasaki M, Kochman J, Koltowski L, Kubo T, Kume T, Kyono H, Lam CC, Lamouche G, Lee DP, Leon MB, Maehara A, Manfrini O, Mintz GS, Mizuno K, Morel MA, Nadkarni S, Okura H, Otake H, Pietrasik A, Prati F, Raber L, Radu MD, Rieber J, Riga M, Rollins A, Rosenberg M, Sirbu V, Serruys PW, Shimada K, Shinke T, Shite J, Siegel E, Sonoda S, Suter M, Takarada S, Tanaka A, Terashima M, Thim T, Uemura S, Ughi GJ, van Beusekom HM, van der Steen AF, van Es GA, van Soest G, Virmani R, Waxman S, Weissman NJ, Weisz G; International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT). Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. J Am Coll Cardiol. 2012 Mar 20;59(12):1058-72. doi: 10.1016/j.jacc.2011.09.079.
- Background: PubMed 21930500Di Mario C, Iakovou I, van der Giessen WJ, Foin N, Adrianssens T, Tyczynski P, Ghilencea L, Viceconte N, Lindsay AC. Optical coherence tomography for guidance in bifurcation lesion treatment. EuroIntervention. 2010 Dec;6 Suppl J:J99-J106. doi: 10.4244/EIJV6SUPJA16.
- Background: PubMed 22763361Karanasos A, Tu S, van der Linden M, van Weenen S, Ligthart J, Regar E. Online 3-dimensional rendering of optical coherence tomography images for the assessment of bifurcation intervention. Can J Cardiol. 2012 Nov-Dec;28(6):759.e1-3. doi: 10.1016/j.cjca.2012.04.017. Epub 2012 Jul 3.
- Individual participant dataSharing planned: No
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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.
Annapoorna Kini, MD MRCP FACC principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 2 inclusion and 8 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 8 Dec 2017. 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 United States. 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?
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?
Procedural success (time frame: Day 1). 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 NCT03058510, which also lists 12 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 8 Dec 2017.