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Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Stent Implantation (OCTACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272283
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Lisbeth Antonsen, Odense University Hospital

Brief Summary:

Coronary artery disease is one of the most prevalent diseases in the western countries.

A waxy substance called plaque can build up inside the coronary arteries. Over time, plaque can harden or rupture, and cause narrowing (stenosis) of the arteries and reduce the flow of oxygen-rich blood to the heart.

The standard treatment of symptomatic coronary stenosis is percutaneous coronary intervention (PCI) with balloon dilation followed by stent implantation.

A stent is a small metallic grid that stabilizes the coronary vessel wall after the balloon dilation.

Currently, drug-eluting stents (DES) are the most widely used stent types. DESs consist of a metallic backbone and an antiprolifetive drug-coating bound by a polymer (glue). These devices have reduced the incidence of excessive formation of new tissue (in-stent restenosis) dramatically in comparison with previously used bare-metal stents.

However, there are "safety concerns" with DES, since later thrombotic events have been reported.

On one hand excessive tissue formation inside the stent can cause in-stent restenosis, and on the other hand insufficient coverage of the stent can cause persistently exposed metalllic material that can induce platelet aggregation and thrombus-formation.

The etiology to stent thrombosis is multifactorial. Possible predisposing factors are, among others: 1) hypersensitivity towards the polymer-coating, which may induce delayed healing inside and around the stent, and 2) insufficient contact between the stent and the underlying coronary vessel wall (incomplete stent apposition), which may cause flow-disturbance and delayed healing.

Delayed healing causes persistently exposed metallic material that can induce platelet aggregation and thrombus-formation.

The Nobori stent is a new-generation DES, coated with a thin layer of drug and a bioabsorbable polymer. The drug is localized on the outer side of the stent, and decreases the release of drug to the blood circulation. The bioabsorbable polymer is degraded after 6-9 months after implantation, and decreases the risk of hypersensitivity-reactions in the vessel wall.

The improved pharmacokinetic profile of the stent is thought to improve the healing pattern.

At routine coronary angiography, a small plastic tube is inserted in the femoral artery under local anesthesia. Thin, flexible catheters are then advanced through the artery system (femoral artery and aorta) to the coronary arteries. Contrast is injected in to the blood stream by the catheters, and the arteries are depicted by a special X-ray technique during dye-release. By angiography, the outer sides of the coronary arteries are visualized, and balloon dilations and stent implantations are guided by this standard technique.

Newer studies have documented that stent placement and expansion is superiorly visualized if supplementary intravascular imaging is performed during stent implantation.

Small imaging catheters are wired through the vessel after stent implantation, and film the stent retrogradely through the vessel.

Intravascular ultrasound (IVUS) visualizes the complete vessel wall by use of sound waves, and stent expansion is evaluated in detail.

Optical coherence tomography (OCT) is a newer light-based, high-resolution technology. The technique can depict every thread (strut) from the stent, enabling visualization of both contact between struts and underlying vessel wall immediately after the procedure, and strut coverage at follow-up.

The purpose of this study is to determine whether OCT-guided PCI can improve healing and coverage of the stent in comparison with routine angiographic guidance alone in patients indicating PCI due to myocardial infarction.

If OCT-guidance improves coverage of the stent, this might lower the later thrombotic risk.

Patients hospitalized due to myocardial infarction are randomized either to OCT-guided or angio-guided stent implantation in the present study. In both groups the Nobori stent is implanted according to standard techniques. In the angio-guided group, implantations are guided by angiography alone. OCT- and IVUS analysis are performed after an angiographic optimal result for documentary reasons. The operator is blinded towards the image findings, and analysis is performed offline later.

In the OCT-guided group, both OCT and IVUS analysis is interpreted immediately after the acquisition. If stent apposition and/or expansion is deemed suboptimal, additional balloon dilation and/or stenting is performed. In case of OCT-driven stent optimization, a documentary OCT and IVUS is performed to document the final result.

Patients are readmitted 6 months later for a control angiogram inclusive OCT to assess stent coverage.

Furthermore, patients are readmitted 12 months after the index procedure for a control angiogram including OCT and IVUS to assess dynamic vessel wall responses.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Infarction Device: Percutaneous coronary intervention with Nobori biolimus-eluting stent implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Nobori Stent Implantation in Patients With Non ST Segment Elevation Myocardial Infarction
Study Start Date : August 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Angio-guided PCI

Patients allocated to "angio-guided PCI" are having Percutaneous Coronary Intervention (PCI) with stent implantation guided by routine angiography alone.

Documentary (comparator) intravascular imaging with Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) is performed. The PCI-operator is blinded to the image aquisitions, and the analysis is performed offline later.

Device: Percutaneous coronary intervention with Nobori biolimus-eluting stent implantation
The third-generation biodegradable polymer Nobori biolimus-eluting stent is implanted in all patients

Experimental: OCT-guided PCI
After obtaining an angiographic optimal result, patients allocated to "OCT-guided PCI" have guiding Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) performed. Online image interpretation is performed by a dedicated OCT-analyst and the PCI-operator. If the OCT reveals; 1) under expansion of the stent with a minimal stent area (MSA) <90% of the distal/proximal reference vessel lumen area and/or; 2) significant acute incomplete stent apposition (defined as more than or equal to 3 stent struts detached >140 microns from the underlying vessel wall), and/or; 3) edge dissection(s) causing significant reduction in minimal lumen area(s) (MLA <4 mm2) and/or, 4) significant residual stenosis (MLA <4 mm2) at the proximal and/or distal reference segment(s), additional intervention is encouraged. The degree of optimization based upon OCT findings is left to the judgement of the PCI-operator.
Device: Percutaneous coronary intervention with Nobori biolimus-eluting stent implantation
The third-generation biodegradable polymer Nobori biolimus-eluting stent is implanted in all patients




Primary Outcome Measures :
  1. Proportion of uncovered struts [ Time Frame: At 6-months follow-up OCT ]
    For each patient/stented segment: Number of uncovered struts divided by the total number of struts, multiplied by 100


Secondary Outcome Measures :
  1. Number/Incidence of OCT-detected edge dissections [ Time Frame: Assessed immediately after the stent implantation ]
    The frequency of angiographically silent edge dissections will be described

  2. Spontaneous healing course of OCT-detected edge dissections [ Time Frame: At 6-months follow-up OCT ]
    The number of residual dissection flaps and/or vessel wall disruptions will be described in relation to findings of edge dissections immediately after stent implantation

  3. Dynamic coronary evaginations [ Time Frame: At 6- and 12-months OCT ]
    Coronary evaginations are outward bulges of the vessel wall between struts. For each evagination observed, a "depth" and an "area" will be measured. Number and magnitude of coronary evaginations will be measured for each patient. Frequencies and magnitudes of these features at 6-months will be compared with frequencies and magnitudes of these features at 12-months

  4. Peri-stent coronary vessel wall remodeling [ Time Frame: IVUS immediately after stent implantation and after 12-months ]
    Remodeling will be assessed using IVUS, by measuring the serial changes in external elastic membrane cross sectional area between these 2 time points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A Non ST segment Elevation Myocardial Infarction (NSTEMI) had been diagnosed
  • A de novo lesion (more than or equal to 50% dimater stenosis) had been visualized on coronary angiography
  • A Percutaneous Coronary Intervention with Drug-Eluting Stent (DES) implantation was indicated

Exclusion Criteria:

  • Patients included in other randomized trials
  • Lifeexpectancy <1 year
  • Allergy to aspirin, clopidogrel, ticagrelor and prasugrel
  • Allergy to limus-agents
  • Ostial lesions (not possible to flush by OCT)
  • S-creatinin >170 micrograms/l
  • Tortuous and extremely calcified lesions where intravascular imaging is deemed associated with an increased risk for the patient
  • Very long lesions (due to the limited pullback length of the OCT system)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lisbeth Antonsen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02272283    
Other Study ID Numbers: S-20110030
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by Lisbeth Antonsen, Odense University Hospital:
PCI optimization
Coronary Remodeling
Drug-Eluting Stent
Optical Coherence Tomography
Intravascular Ultrasound
Strut Coverage
Strut Apposition
Vascular Healing Pattern
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases