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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).
This is a prospective observational multicenter cohort study of all patients with calcified coronary lesions undergoing RA in participating centres across Asia. Patients will be required to provide informed consent for data collection, including follow-up data and uploading of data on a web-based data collection platform (deidentified). Operators/ institution coordinators will fill up hardcopy or electronic (web-based) forms including patient's baseline demographics, co-morbidities, clinical data, laboratory test results, echocardiography results, coronary angiography findings with subsequent interventions performed as well as follow-up clinical and laboratory results. Note that while detailed data for individual patients will only be collected if there is informed consent, data from each institution will also be collected for aggregate data regarding procedural volume (eg. total cases with debulking therapy and specifically for ROTABLATORTM). This will give a sense of representativeness of data collected. This screening data will also include the following fields: age, gender, ethnicity, comorbidities, target vessel, prior revascularization (PCI/CABG), clinical presentation, procedural urgency, angiographic procedural details (RA and PCI) and in-hospital complication and mortality. The use of this retrospective data will require appropriate approval and will only utilize anonymized data. Only in-hospital data will be obtained and no follow up data is required from these controls. Should these data not be available in any of the participating sites, a minimum baseline demographics, procedural and inpatient outcome data with reasons for non-participation in registry should be provided for records purposes. This shall be accepted as a limitation of the study. Sub-site analysis may be performed in centres with availability of all data in this group of patients to address generalisability of the data collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study) | Informed consent to be obtained either prior to PCI with rotational atherectomy planned or within 48 hours after rotational atherectomy. There will be data collection of history/demographics, laboratory results, symptoms, any serious adverse events recording for this cohort as well as a telephone follow up at 12months post rotational atherectomy. |
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| Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study) | Subjects that were demised or refused to give consent will fall under this cohort. The data collection of this cohort will be done through screening of in-hospital data via available local PCI database/registry. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational Atherectomy | Procedure | Rotational atherectomy (RA) has been the most used atherectomy modality since its first inception in1988. RA uses high speed rotation (140,000 - 180,000 rpm) to ablate inelastic plaque, resulting in debris averaging 5µm in size24. The main focus of RA in the era of DES stent has been on plaque modification rather that plaque debulking with more papers showing improved PCI success rates. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint (Procedural success) | Procedural success defined as < 20% residual stenosis in treated segment without on-table mortality with TIMI 3 flow. | Duration of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Death | in-hospital and at 1-year follow-up | 1 year |
| Periprocedural myocardial infarction (MI) |
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Inclusion Criteria:
Able to understand and sign an informed consent form
Presence of clinical indication for percutaneous coronary intervention (PCI) and/or stent placement
Subjects willing to comply with all research and follow-up requirements.
Angiographic criteria (ONE of the following criteria MUST be met)
Procedural criteria
All patients treated with RA with or without other forms of debulking therapy
Exclusion Criteria:
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All patients with signed informed consent for percutaneous coronary intervention (PCI) and are eligible for calcium debulking treatment with rotational atherectomy with or without other forms of calcium debulking therapies will be enrolled into this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Low | Contact | 67042280 | james.low.j.y@nhcs.com.sg | |
| Phoebe Chin | Contact | 67042268 | chin.ting.ting@nhcs.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Khung Keong Yeo | Singhealth Foundation | Principal Investigator |
| Shoichi Kuramitsu | Kokura Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokura Memorial hospital | Recruiting | Kitakyushu | 802-8555 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28258729 | Background | Lee MS, Park KW, Shlofmitz E, Shlofmitz RA. Comparison of Rotational Atherectomy Versus Orbital Atherectomy for the Treatment of Heavily Calcified Coronary Plaques. Am J Cardiol. 2017 May 1;119(9):1320-1323. doi: 10.1016/j.amjcard.2017.01.025. Epub 2017 Feb 10. | |
| 31084239 | Background | Sharma SK, Tomey MI, Teirstein PS, Kini AS, Reitman AB, Lee AC, Genereux P, Chambers JW, Grines CL, Himmelstein SI, Thompson CA, Meredith IT, Bhave A, Moses JW. North American Expert Review of Rotational Atherectomy. Circ Cardiovasc Interv. 2019 May;12(5):e007448. doi: 10.1161/CIRCINTERVENTIONS.118.007448. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2021 | Feb 1, 2021 |
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|
| within 48 hours of procedure |
| Complications | Significant coronary perforation at least Type II, III or III CS based on Ellis classification | within 48 hours of procedure |
| Complication | no-reflow or slow flow | within 48 hours of procedure |
| Procedural time | Time of guide engagement to removal of guide | Duration of procedure |
| National Heart Centre Singapore | Recruiting | Singapore | 169609 | Singapore |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D017225 | Atherectomy, Coronary |
| ID | Term |
|---|---|
| D017073 | Atherectomy |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D062645 | Percutaneous Coronary Intervention |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |
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