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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice. OA is a procedure that uses a tiny spinning tool to gently remove hard calcium from inside an artery, helping to open the vessel so other treatments-like balloons or stents-can work better. The study focuses on people who have heavily calcified arteries in the femoropopliteal or infrapopliteal areas of the leg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions | Eligible patients are those who will undergo OA prior to any adjunctive endovascular procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stealth 360™ Peripheral Orbital Atherectomy System from Abbott | Device | The Stealth 360™ Peripheral Orbital Atherectomy System uses a diamond-coated, eccentrically mounted crown with bi-directional capabilities that treat a wide range of vessels, enabling single device treatment of multiple lesions and vessel sizes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lesions with ≤30% residual stenosis after completion of full planned procedure | Defined as residual stenosis ≤30%, immediately after completion of full planned procedure (OA + any planned adjunctive intervention(s)). | Immediately after procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lesions with ≤30% residual stenosis after any unplanned endovascular intervention(s) | Defined as residual stenosis ≤30% immediately after completion of additional unplanned endovascular intervention(s) (any endovascular procedure that was not part of the primary procedure plan). | Immediately after procedure completion |
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Inclusion Criteria:
Exclusion Criteria:
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Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions treated with OA using the Stealth 360 Peripheral OA System for vessel preparation prior to any adjunctive endovascular procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Poulet, PhD | Contact | +41 79 385 16 78 | oracue@cirse.org | |
| Dhwani S. Korde, PhD | Contact | +4367762942469 | oracue@cirse.org |
| Name | Affiliation | Role |
|---|---|---|
| Gerd Grözinger, Prof. Dr. med. | SLK Kliniken Heilbronn GmbH | Study Chair |
| Marianne Brodmann, Univ.-Prof. Dr. med. | Medizinische Universität Graz | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24342060 | Background | Nordanstig J, Wann-Hansson C, Karlsson J, Lundstrom M, Pettersson M, Morgan MB. Vascular Quality of Life Questionnaire-6 facilitates health-related quality of life assessment in peripheral arterial disease. J Vasc Surg. 2014 Mar;59(3):700-7. doi: 10.1016/j.jvs.2013.08.099. Epub 2013 Dec 15. | |
| 28584945 | Background |
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|
|
| Need for unplanned bailout stenting |
Defined as any stent placement that was not part of the primary procedure plan. |
| Immediately after procedure completion |
| Number of participants free from Clinically-Driven Target Lesion Revascularization (CD-TLR) | Defined as freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion. | 12 and 24 months |
| CD-TLR-free survival | Defined as time between first OA procedure and any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion. | Until the end of the follow-up period of 2 years |
| Clinical response using Rutherford classification categories | The Rutherford classification is a clinical scale used to categorize the severity of peripheral arterial disease: Category 0 = asymptomatic; Category 1 = mild claudication; Category 2 = moderate claudication; Category 3 = severe claudication; Category 4 = ischemic rest pain; Category 5 = minor tissue loss; Category 6 = severe tissue loss. | 12 and 24 months |
| Wound status | Defined as healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening). | 12 and 24 months |
| Freedom from amputation of the target limb | Defined as absence of any amputation of the target limb (above ankle). | 12 and 24 months |
| Amputation-free survival | Defined as time between first OA procedure and above-ankle amputation of the target limb. | Until the end of the follow-up period of 2 years |
| Overall survival | Defined as the time between the first OA procedure and death of any cause. | Until the end of the follow-up period of 2 years |
| Patient-reported health-related quality-of-life | Measured by Vascular Quality of Life Questionnaire - 6 items (VascuQol-6), which is a short patient-reported outcome measure (PROM), used to assess health-related quality of life in people with PAD. It consists of 6 questions, each scored from 1 to 7, with 1 as the worst possible quality of life and 7 as the best possible quality of life. Higher overall scores reflect better quality of life for patients with PAD. | Baseline, 6, 12 and 24 months post treatment |
| Frequency and severity of procedural complications and other adverse events | Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe. | Within 30 days after the OA procedure |
| Clinical response using ankle-brachial index (ABI) | The ankle-brachial index (ABI) is a non-invasive measure calculated as the ratio of systolic blood pressure at the ankle to systolic blood pressure at the arm. ABI categories commonly used to classify peripheral arterial disease are: >1.40 = non-compressible arteries; 1.00-1.40 = normal; 0.91-0.99 = borderline; 0.41-0.90 = mild to moderate peripheral arterial disease; <0.40 = severe peripheral arterial disease. | 12 and 24 months |
| Clinical response using toe pressure | The toe pressure test measures distal limb perfusion by recording systolic pressure at the toe. In CLTI patients, toe pressure ≤30 mmHg is commonly used to indicate severe ischemia, while values >30 mmHg suggest better perfusion. | 12 and 24 months |
| Clinical response using WIfi (wound, ischemia and foot infection) score | The WIfI classification is a staging system used to assess CLTI based on wound extent, ischemia severity, and foot infection. Each component is graded from 0 (none) to 3 (severe). Lower WIfI scores indicate a lower risk of limb loss and a lesser urgency for revascularization, whereas higher scores indicate greater disease severity, higher amputation risk, and greater potential benefit from revascularization. | 12 and 24 months |
| Raghu Lakshminarayan, Dr |
| Hull University Teaching Hospitals NHS Trust |
| Study Chair |
| Stefan Müller-Hülsbeck, Prof. Dr. med. | DIAKO Krankenhaus gGmBH | Study Chair |
| Filippiadis DK, Binkert C, Pellerin O, Hoffmann RT, Krajina A, Pereira PL. Cirse Quality Assurance Document and Standards for Classification of Complications: The Cirse Classification System. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1141-1146. doi: 10.1007/s00270-017-1703-4. Epub 2017 Jun 5. |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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