Chronic Limb Threatening IschemiaORACLENCT07270562
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
An observational study of Chronic Limb Threatening Ischemia and Chronic Limb-Threatening Ischemia, run by Cardiovascular and Interventional Radiological Society of Europe at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
- What is being tested?
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2026to Dec 2031
- Phase
- Observational
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: 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.
Who may be able to join
- Rutherford classification category ≥4;
- Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System;
- Calcification of target lesions must be visible on fluoroscopy or CT-angiography;
- Patients competent and willing to provide informed consent.
Who cannot join
- Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);
- Inadequate inflow (>30% stenosis) following optimization;
- Insufficient direct outflow (less than 1 run-off vessel);
- Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;
- Patients planned to receive an above ankle amputation of the target limb;
- Patients enrolled in RESCUE (ClinicalTrials.gov ID NCT07270575).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Raghu Lakshminarayan, Dr
About this study
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.
- Being tested
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Keywords
- CLTI, Peripheral artery disease, Orbital atherectomy, Observational cohort study, Chronic limb ischemia, Critical limb-threatening ischemia, Calcified peripheral artery lesions, Vessel preparation, Femoropopliteal arteries, Infrapopliteal arteries, OA, Atherectomy for calcified lesions
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stealth 360™ Peripheral Orbital Atherectomy System from AbbottDevice
Also called Orbital Atherectomy, Orbital Atherectomy System
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions | Eligible patients are those who will undergo OA prior to any adjunctive endovascular procedure Receives: Device: Stealth 360™ Peripheral Orbital Atherectomy System from Abbott |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: Immediately after procedure completion
Secondary outcomes (14)
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).
Measured: Immediately after procedure completion
Need for unplanned bailout stenting
Defined as any stent placement that was not part of the primary procedure plan.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 and 24 months
Wound status
Defined as healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening).
Measured: 12 and 24 months
Freedom from amputation of the target limb
Defined as absence of any amputation of the target limb (above ankle).
Measured: 12 and 24 months
Amputation-free survival
Defined as time between first OA procedure and above-ankle amputation of the target limb.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start31 Aug 2026
- Primary completionAug 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb Threatening IschemiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiovascular and Interventional Radiological Society of Europe
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Gerd Grözinger, Prof. Dr. med., Study chair, SLK Kliniken Heilbronn GmbHMarianne Brodmann, Univ.-Prof. Dr. med., Study chair, Medizinische Universität GrazRaghu Lakshminarayan, Dr, Study chair, Hull University Teaching Hospitals NHS TrustStefan Müller-Hülsbeck, Prof. Dr. med., Study chair, DIAKO Krankenhaus gGmBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270562
- Sponsor's protocol ID
- ORACLE
- Acronym
- ORACLE
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24342060Filippiadis 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.
PubMed 28584945