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| Name | Class |
|---|---|
| Cardiovascular Research Foundation, New York | OTHER |
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The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.
Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.
After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary PCI guided by IVUS | Active Comparator | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. |
|
| Coronary PCI guided by OCT | Active Comparator | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. |
|
| Coronary PCI guided by Angiography | Active Comparator | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary PCI guided by IVUS | Procedure | Imaging type |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) | Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows:
If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms. | Post-procedure within 1 hour |
| Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, pericardiocentesis, thrombus aspiration and other). | During procedure, an average of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Procedural Success | Acute procedural success are classified as: A) Optimal (%) The MSA of the proximal segment is ≥95% of the proximal reference lumen area and the MSA of the distal segment is ≥95% of the distal reference lumen area. B) Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. C) Optimal and Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. D) Unacceptable (%) The MSA of the proximal segment is <90% of the proximal lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area. |
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General Inclusion Criteria:
Age ≥ 18 years.
Patient with an indication for PCI including:
Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
Signed written informed consent
Angiographic inclusion criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziad Ali, MD | Columbia Presbyterian Medical Center (NY) | Principal Investigator |
| Gregg W Stone, MD | Columbia Presbyterian Medical Center (NY) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35249 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32540793 | Derived | Ali ZA, Karimi Galougahi K, Maehara A, Shlofmitz RA, Fabbiocchi F, Guagliumi G, Alfonso F, Akasaka T, Matsumura M, Mintz GS, Ben-Yehuda O, Zhang Z, Rapoza RR, West NEJ, Stone GW. Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial. EuroIntervention. 2021 Jan 20;16(13):1085-1091. doi: 10.4244/EIJ-D-20-00498. | |
| 27806900 |
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Of the 1759 subjects consented, 1309 subjects were not randomized due to failed screening (n=1230), roll-in subjects (n=74), withdrawal of consent (n=1), withdrawal by the investigator (n=3) and software malfunction (n=1).
A total of 1,759 subjects were initially consented, however only 450 subjects were actually randomized and enrolled into the trial across 29 sites. The first randomized subject was enrolled on May 13, 2015, and the last randomized subject was enrolled on April 5, 2016. Each site was allowed to enroll a maximum of 65 subjects in the trial. The subjects were followed through 12-months and the last subject follow-up visit was completed on April 25, 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coronary PCI Guided by OCT | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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For those subjects randomized to the IVUS or Angiography treatment arms, the operating investigator at the site was blinded to the final post-PCI OCT run for the subject.
| Coronary PCI guided by OCT | Procedure | Imaging type |
|
|
| Coronary PCI guided by Angiography | Procedure | Imaging type |
|
| During procedure, an average of 1 hour |
| Rate of Post-PCI Stent Expansion (%) | Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100. | Up to 1 hour post-procedure |
| Rate of Mean Stent Expansion (%) | Mean stent expansion is defined as the mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100. | During procedure, an average of 1 hour |
| Number of Participants With Plaque Protrusion and Thrombus | Plaque protrusion and thrombus is defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria: Protrusion is defined as any mass at least 0.2 mm beyond the luminal edge of a strut and will be further classified as Major and Minor. Major: Protrusion area/Stent area at site of tissue protrusion ≥10% Minor: Protrusion area/Stent area at site of tissue protrusion<10% | During procedure, an average of 1 hour |
| Number of Participants With Untreated Reference Segment Disease | Untreated reference segment disease is defined as untreated Mean Lumen Area (MLA) ≤60% of the adjacent reference segment lumen area up to 10 mm from the proximal and distal stent edges. | During procedure, an average of 1 hour |
| Number of Participants With Edge Dissections | Edge Dissections are classified as A) Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length C) All (Major and Minor) Edge dissections will be further classified as: I. Intimal (limited to the intima layer, i.e. not extending beyond the internal elastic lamina) II. Medial (extending into the media layer) III. Adventitial (extending through the external elastic membrane | During procedure, an average of 1 hour |
| Number of Participants With Stent Malapposition | Frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). Malapposition will be further classified as: Major: if associated with unacceptable stent expansion Minor: if not associated with significant under-expansion | During procedure, an average of 1 hour |
| Number of Participants With Border Detection (OCT Arm Only) | The visibility of the vessel external elastic lamina (EEL) border by OCT will be evaluated at both reference sites (proximal and distal) and the MSA before AND after intervention and then classified into 3 grades: A) Good: ≥75% (270°) of visible circumference B) Moderate: ≥50% (180°) - <75% (270°) of visible circumference C) Poor: <50% (180°) of visible circumference | Pre-PCI OCT Run procedure |
| Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | Clinical decision making will be assessed on the basis of the post-stent imaging run | During procedure, an average of 1 hour |
| Median Intra-stent Lumen Area (Intra-stent Flow Area) | Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion | Up to 1 hour post-procedure |
| Median Effective Lumen Area (Total Flow Area) | Effective lumen area (Total flow area) is defined as Intra-stent Lumen Area plus any area of malapposition between the stent and the vessel wall (lumen border/plaque border). | Up to 1 hour post-procedure |
| IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts | During procedure, an average of 1 hour |
| IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts | During procedure, an average of 1 hour |
| IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts | During procedure, an average of 1 hour |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter | Baseline |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter | Final Post-PCI, up to 1 hour after PCI procedure |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | Angiographic Endpoints (QCA) will be assessed as diameter stenosis | Baseline |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | Angiographic Endpoints (QCA) will be assessed as diameter stenosis | Final Post-PCI, up to 1 hour after PCI procedure |
| Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention | Final Post-PCI, up to 1 hour after PCI procedure |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters. | Baseline |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters. | Final Post-PCI, up to 1 hour after PCI procedure |
| Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B | Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B | Final Post-PCI, up to 1 hour after PCI procedure |
| Procedural Endpoints (Site Reported): Median Total Stent Length | Median Total Stent Length will be measured in millimeters. | During procedure, an average of 1 hour |
| Procedural Endpoints (Site Reported): Median Stents Per Lesion | Median Stents per lesion will be measured in counts | During procedure, an average of 1 hour |
| Procedural Endpoints (Site Reported) - Median Maximal Stent Size | Median Maximal stent size will be measured in millimeters. | During procedure, an average of 1 hour |
| Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations | Post dilatation inflations will be assessed in terms of use of balloon inflations | During procedure, an average of 1 hour |
| Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) | Median Maximum inflation pressure will be measured in atm. | During procedure, an average of 1 hour |
| Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Participants will be analyzed for the use of additional inventions Additional interventions used on the basis of the post stent imaging run will be either use of Larger Balloon, Use of Higher Inflation Pressures, Use of Additional Inflations, Use of Additional Stent(s), Thrombus Aspiration, or Other Interventions | During procedure, an average of 1 hour |
| Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate | Angiography defined procedural success rate is defined as a final lesion angiographic diameter stenosis <30% (QCA) and TIMI III flow (QCA) without dissection ≥ NHLBI type C, perforation, prolonged chest pain or ST segment elevation or depression changes (>30 minutes), or procedural death. | During procedure, an average of 1 hour |
| Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate | Device success rate (site reported): Successful OCT or IVUS imaging obtained pre and post PCI in the respective arms (does not include blinded OCT runs in the IVUS and Angiography arms) | During procedure, an average of 1 hour |
| Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure (TLF) at 1 year defined as cardiovascular death, target vessel myocardial infarction, or ischemia driven target-lesion revascularization. Target lesion is defined as the lesion designated for randomization to OCT vs. IVUS vs. Angiography. | 1 year |
| Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction | Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year | 1 Year |
| Scottsdale Healthcare Shea |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| University of California at San Diego (UCSD) Medical Center | San Diego | California | 92037 | United States |
| Heart Institute of Colorado | Broomfield | Colorado | 80021 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| New York Presbyterian Hospital/Columbia University | New York | New York | 10032 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Eastern Cardiology | Greenville | North Carolina | 27834 | United States |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| St. Charles Medical Center | Bend | Oregon | 97701 | United States |
| Austin Heart | Austin | Texas | 78705 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| The University of Texas Health Science at San Antonio | San Antonio | Texas | 78229 | United States |
| Onze-Lieve-Vrouwziekenhuis Campus Aalst | Aalst | East Flanders | 9300 | Belgium |
| Klinikum der Justus-Liebig-Universität | Giessen | Hesse | 35392 | Germany |
| Ospedale Papa Giovanni XXIII | Bergamo | Lombardy | 24127 | Italy |
| Centro Cardiologico Monzino | Milan | Lombardy | 20138 | Italy |
| Kobe University Hospital | Chuo-ku | Hyōgo | 650-0017 | Japan |
| Nara Medical University Hospital | Kashihara-shi | Nara | 634-8521 | Japan |
| Osaka Saiseikai Nakatsu Hospital | Osaka | Osaka | 530-0012 | Japan |
| Wakayama Medical University Hospital | Wakayama | Wakayama | 641-8510 | Japan |
| Yamaguchi University Hospital | Ube-shi | Yamaguchi | 755-0046 | Japan |
| Erasmus MC - Thoraxcenter | Rotterdam | South Holland | 3015 CE | Netherlands |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Kings College Hospital | Brixton | London | SE5 9RS | United Kingdom |
| Derived |
| Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30. |
| FG001 |
| Coronary PCI Guided by IVUS |
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type |
| FG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coronary PCI Guided by OCT | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type |
| BG001 | Coronary PCI Guided by IVUS | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type |
| BG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) | Post-PCI MSA will be assessed by OCT in each randomized arm, measured at the independent OCT core laboratory blinded to imaging modality assignment. Hierarchal manner testing will be as follows:
If the OCT guided stenting arm was found to be superior to the IVUS guided stenting arm, then the superiority of OCT to IVUS will be tested for the mean difference between the post PCI MSA for the OCT and IVUS arms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Median | Inter-Quartile Range | mm^2 | Post-procedure within 1 hour |
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| Primary | Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) | Procedural MACE defined as procedural complications (angiographic dissection, perforation, thrombus, and acute closure) requiring active interventions (prolonged balloon inflations, additional stent implantations, pericardiocentesis, thrombus aspiration and other). | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Number of Participants With Acute Procedural Success | Acute procedural success are classified as: A) Optimal (%) The MSA of the proximal segment is ≥95% of the proximal reference lumen area and the MSA of the distal segment is ≥95% of the distal reference lumen area. B) Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. C) Optimal and Acceptable (%) The MSA of the proximal segment is ≥90% and <95% of the proximal reference lumen area and the MSA of the distal segment is ≥90% and <95% of the distal reference lumen area. D) Unacceptable (%) The MSA of the proximal segment is <90% of the proximal lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Rate of Post-PCI Stent Expansion (%) | Post-PCI stent expansion is defined as the minimum stent area divided by the average of proximal and distal reference lumen areas x 100. | The number of participants analyzed includes subjects who were available at that time of analysis. | Posted | Mean | Standard Deviation | percentage of stent expansion | Up to 1 hour post-procedure |
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| Secondary | Rate of Mean Stent Expansion (%) | Mean stent expansion is defined as the mean stent area (stent volume/analyzed stent length) divided by the average of proximal and distal reference lumen areas x 100. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Median | Inter-Quartile Range | percentage of mean stent expansion | During procedure, an average of 1 hour |
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| Secondary | Number of Participants With Plaque Protrusion and Thrombus | Plaque protrusion and thrombus is defined as a mass attached to the luminal surface or floating within the lumen, meeting the following criteria: Protrusion is defined as any mass at least 0.2 mm beyond the luminal edge of a strut and will be further classified as Major and Minor. Major: Protrusion area/Stent area at site of tissue protrusion ≥10% Minor: Protrusion area/Stent area at site of tissue protrusion<10% | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Number of Participants With Untreated Reference Segment Disease | Untreated reference segment disease is defined as untreated Mean Lumen Area (MLA) ≤60% of the adjacent reference segment lumen area up to 10 mm from the proximal and distal stent edges. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Number of Participants With Edge Dissections | Edge Dissections are classified as A) Major (%): ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length C) All (Major and Minor) Edge dissections will be further classified as: I. Intimal (limited to the intima layer, i.e. not extending beyond the internal elastic lamina) II. Medial (extending into the media layer) III. Adventitial (extending through the external elastic membrane | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Number of Participants With Stent Malapposition | Frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). Malapposition will be further classified as: Major: if associated with unacceptable stent expansion Minor: if not associated with significant under-expansion | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Number of Participants With Border Detection (OCT Arm Only) | The visibility of the vessel external elastic lamina (EEL) border by OCT will be evaluated at both reference sites (proximal and distal) and the MSA before AND after intervention and then classified into 3 grades: A) Good: ≥75% (270°) of visible circumference B) Moderate: ≥50% (180°) - <75% (270°) of visible circumference C) Poor: <50% (180°) of visible circumference | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | Pre-PCI OCT Run procedure |
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| Secondary | Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run | Clinical decision making will be assessed on the basis of the post-stent imaging run | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Median Intra-stent Lumen Area (Intra-stent Flow Area) | Intra-stent Lumen Area (Intra-stent Flow Area) is defined as stent area minus any protrusion | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Median | Inter-Quartile Range | mm^2 | Up to 1 hour post-procedure |
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| Secondary | Median Effective Lumen Area (Total Flow Area) | Effective lumen area (Total flow area) is defined as Intra-stent Lumen Area plus any area of malapposition between the stent and the vessel wall (lumen border/plaque border). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Median | Inter-Quartile Range | mm^2 | Up to 1 hour post-procedure |
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| Secondary | IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) | Dissection (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) | Malapposition (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) | Protrusion (Major, Minimal, All) will be compared between IVUS and OCT Imaging cohorts | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | mm | Baseline |
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| Secondary | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter | Angiographic Endpoints (QCA) will be assessed as Minimal lumen diameter | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | mm | Final Post-PCI, up to 1 hour after PCI procedure |
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| Secondary | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | Angiographic Endpoints (QCA) will be assessed as diameter stenosis | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | percentage of Diameter Stenosis | Baseline |
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| Secondary | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis | Angiographic Endpoints (QCA) will be assessed as diameter stenosis | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | percentage of Diameter Stenosis | Final Post-PCI, up to 1 hour after PCI procedure |
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| Secondary | Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention | Angiographic Endpoints (QCA) will be assessed as Acute lumen gain post-intervention | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | mm | Final Post-PCI, up to 1 hour after PCI procedure |
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| Secondary | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters. | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | mm | Baseline |
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| Secondary | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio | Angiographic Endpoints (QCA) will be assessed as Maximum stent size/reference vessel diameter ratio. Maximum stent size refers to the largest stent diameter used in a treated segment. If only one stent was used, it is that stent diameter. If more than one stent were used, it is the larger of the stent diameters. | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | mm | Final Post-PCI, up to 1 hour after PCI procedure |
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| Secondary | Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B | Angiographic Endpoints (QCA) will be assessed as Angiographic dissection ≥ NHLBI type B | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Count of Participants | Participants | Final Post-PCI, up to 1 hour after PCI procedure |
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| Secondary | Procedural Endpoints (Site Reported): Median Total Stent Length | Median Total Stent Length will be measured in millimeters. | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | mm | During procedure, an average of 1 hour |
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| Secondary | Procedural Endpoints (Site Reported): Median Stents Per Lesion | Median Stents per lesion will be measured in counts | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | Stents per lesion | During procedure, an average of 1 hour |
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| Secondary | Procedural Endpoints (Site Reported) - Median Maximal Stent Size | Median Maximal stent size will be measured in millimeters. | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | mm | During procedure, an average of 1 hour |
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| Secondary | Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations | Post dilatation inflations will be assessed in terms of use of balloon inflations | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | Number of inflations | During procedure, an average of 1 hour |
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| Secondary | Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) | Median Maximum inflation pressure will be measured in atm. | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Median | Inter-Quartile Range | atm | During procedure, an average of 1 hour |
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| Secondary | Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions | Participants will be analyzed for the use of additional inventions Additional interventions used on the basis of the post stent imaging run will be either use of Larger Balloon, Use of Higher Inflation Pressures, Use of Additional Inflations, Use of Additional Stent(s), Thrombus Aspiration, or Other Interventions | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate | Angiography defined procedural success rate is defined as a final lesion angiographic diameter stenosis <30% (QCA) and TIMI III flow (QCA) without dissection ≥ NHLBI type C, perforation, prolonged chest pain or ST segment elevation or depression changes (>30 minutes), or procedural death. | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate | Device success rate (site reported): Successful OCT or IVUS imaging obtained pre and post PCI in the respective arms (does not include blinded OCT runs in the IVUS and Angiography arms) | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Count of Participants | Participants | During procedure, an average of 1 hour |
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| Secondary | Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) | Target Lesion Failure (TLF) at 1 year defined as cardiovascular death, target vessel myocardial infarction, or ischemia driven target-lesion revascularization. Target lesion is defined as the lesion designated for randomization to OCT vs. IVUS vs. Angiography. | Full Analysis Set (FAS) consists of all randomized subjects assigned to treatment per randomization. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction | Number of Participants With Periprocedural Myocardial Infarction will be assessed at 1 year | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | 1 Year |
|
1 Year
All-Cause Mortality and Serious Adverse Events were monitored and analyzed. Non-serious adverse event information was not monitored for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coronary PCI Guided by OCT | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed. Coronary PCI guided by OCT: Imaging type | 2 | 158 | 37 | 158 | 0 | 0 |
| EG001 | Coronary PCI Guided by IVUS | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results. Coronary PCI guided by IVUS: Imaging type | 2 | 146 | 25 | 146 | 0 | 0 |
| EG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type | 0 | 146 | 26 | 146 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Coronary restenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Unstable angina | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Coronary perforation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sustained ventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Allergic drug reaction | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia caused by Gram-Negative Bacilli | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia caused by Haemophilus Influenzae | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Acute viral hepatitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| In-stent restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Trauma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Hyponatremia | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Elevated troponin | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Arm pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Colon polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| |
| Seizure/convulsions/epilepsy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Transient ischemic attack (TIA) | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Urinary tract infections | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| VASC vessel perforation | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vascular dissection | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vasc pseudoaneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Arterial hypertension/hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Left main dissection | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristina M Gibbens, Senior Clinical Project Manager | Abbott | +1 651-756-3859 | Kristina.gibbens@abbott.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018084 | Ultrasonography, Interventional |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
Not provided
Not provided
|
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|
|
| Belgium |
|
|
| United States |
|
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| Japan |
|
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| Italy |
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| United Kingdom |
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| Germany |
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| Spain |
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| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation.
At the end of the procedure, a final IVUS imaging run must be performed.
After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.
Coronary PCI guided by IVUS: Imaging type
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| Coronary PCI Guided by Angiography |
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| Coronary PCI Guided by Angiography |
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography:Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with angiography guidance according to local standard practice.
At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Coronary PCI guided by Angiography: Imaging type
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with angiography guidance according to local standard practice.
At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Coronary PCI guided by Angiography: Imaging type
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| Coronary PCI Guided by Angiography |
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with angiography guidance according to local standard practice.
At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Coronary PCI guided by Angiography: Imaging type
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with angiography guidance according to local standard practice.
At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Coronary PCI guided by Angiography: Imaging type
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with angiography guidance according to local standard practice.
At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Coronary PCI guided by Angiography: Imaging type
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES).
Stenting will be performed with angiography guidance according to local standard practice.
At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
Coronary PCI guided by Angiography: Imaging type
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 |
| Coronary PCI Guided by Angiography |
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
| OG002 | Coronary PCI Guided by Angiography | Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results. Coronary PCI guided by Angiography: Imaging type |
|
|