Orbital AtherectomyOrFitANCT07105930
Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach
A study testing Debulging approach using the orbital atherectomy system and Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy in people with Orbital Atherectomy, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.
Trial summary
Some patients with coronary artery disease have severely calcified vessels. In these cases, placing a stent - a small tube that helps keep the artery open - can be very difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Atherectomy
- What is being tested?
- Debulging approach using the orbital atherectomy system and Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteGermany
- Study dates
- 30 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 Years
- Chronic coronary syndrome with a clinical indication for percutaneous coronary intervention of a severely calcified lesion as defined by coronary computer tomography (CT; Agatston Score of target lesion ≥453 OR Calcium Arc >270°). The determination of calcification in the target lesion is based on native and contrast enhanced CT scans that are conducted as per clinical guidelines. The CT images must not be older than 6 months at the time of patient enrollment.
- Signed informed consent
- The patient is an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy
Who cannot join
- Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours
- Cardiogenic shock
- Chronic total occlusion of the target lesion
- Glomerular filtration rate < 30 ml/min/1.73 m2
- Known presence, at the time of enrollment, of any contraindications listed in the Instructions for Use (IFU) of the investigational device:
- The OCT (optical coherence tomography) imaging catheter cannot cross
Show all 15Show fewer
- The wire or imaging catheter cannot cross
- The target lesion is within a bypass graft or stent
- The patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy.
- The patient has angiographic evidence of thrombus
- The patient has only one open coronary vessel
- The patient has angiographic evidence of flow reducing dissection at the treatment site
- The patient has a known hypersensitivity to egg-, soy-, or peanut protein or to any of the active substances or excipients of the ViperSlide™ lubricant
- Pregnancy (assessed by clinical routine testing)
- Participation in another interventional clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jelena Weller contact
Germany1 site, 1 recruiting
- Recruiting
Universitäres Herz - und Gefäßzentrum, Unversitätsklinikum Frankfurt
Frankfurt
Marco Ochs, PD Dr. med.
About this study
Official title: A Randomized Controlled Multicentric Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach
Some patients with coronary artery disease have severely calcified vessels. In these cases, placing a stent - a small tube that helps keep the artery open - can be very difficult. Calcium build-up in the artery wall may prevent the stent from expanding properly, increasing the risk of complications or failure of the treatment.
To prepare these vessels before stenting, doctors use special techniques to modify or remove the calcium. These techniques are known as plaque modification strategies and can include devices such as atherectomy systems, scoring balloons, or intravascular lithotripsy. However, there is no clear standard as to which strategy is best.
Read more
Purpose of the Study:
This study compares two different approaches to treating calcified coronary arteries before stenting:
- A uniform approach using only the orbital atherectomy system (Diamondback 360®, Abbott), which sands away the calcium with a rotating crown
- A tailored approach, where the operator chooses from various available methods (e.g., rotational atherectomy, scoring or cutting balloons, or shockwave therapy) based on the patient's specific type of calcium The goal is to determine whether the uniform orbital atherectomy approach is not worse (non-inferior) than the individualized method when it comes to how well the stent expands inside the artery.
This is a randomized, controlled clinical trial. Patients will be randomly assigned to one of the two groups.
Randomization ensures fair comparison between both groups. The decision to implant a stent and to use additional techniques is at the discretion of the interventional cardiologist.
- Conditions
- Orbital Atherectomy
- Being tested
- Debulging approach using the orbital atherectomy system, Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debulging approach using the orbital atherectomy systemDevice
A uniform approach using only the orbital atherectomy system (Diamondback 360®), which sands away the calcium with a rotating crown
Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapyProcedure or surgery
A tailored approach, where the operator chooses from various available methods based on the patient's specific type of calcium
| Study group | Role | What they receive |
|---|---|---|
| Debulging with the orbital atherectomy system (Diamondback 360®) | Experimental | Not described Receives: Device: Debulging approach using the orbital atherectomy system |
| Debulging with various available methods | Active comparator | Not described Receives: Procedure: Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-procedural Minimal Stent Area (MSA %) as assessed by optical coherence to-mography (OCT) imaging
Measured: MSA will be assessed in the final OCT run performed after stent implantation withine baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start30 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital AtherectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Ochs, PD Dr., Principal investigator, Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105930
- Sponsor's protocol ID
- MDR-005
- Acronym
- OrFitA
- Status last verified
- Nov 2026
- First submitted
- 25 Jul 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicentric Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach
- ClinicalTrials.gov ID
- NCT07105930
- Acronym / sponsor ID
- OrFitA / MDR-005
- Conditions
- Orbital Atherectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some patients with coronary artery disease have severely calcified vessels. In these cases, placing a stent - a small tube that helps keep the artery open - can be very difficult. Calcium build-up in the artery wall may prevent the stent from expanding properly, increasing the risk of complications or failure of the treatment.
To prepare these vessels before stenting, doctors use special techniques to modify or remove the calcium. These techniques are known as plaque modification strategies and can include devices such as atherectomy systems, scoring balloons, or intravascular lithotripsy. However, there is no clear standard as to which strategy is best.
Purpose of the Study:
This study compares two different approaches to treating calcified coronary arteries before stenting:
- A uniform approach using only the orbital atherectomy system (Diamondback 360®, Abbott), which sands away the calcium with a rotating crown
- A tailored approach, where the operator chooses from various available methods (e.g., rotational atherectomy, scoring or cutting balloons, or shockwave therapy) based on the patient's specific type of calcium The goal is to determine whether the uniform orbital atherectomy approach is not worse (non-inferior) than the individualized method when it comes to how well the stent expands inside the artery.
This is a randomized, controlled clinical trial. Patients will be randomly assigned to one of the two groups.
Randomization ensures fair comparison between both groups. The decision to implant a stent and to use additional techniques is at the discretion of the interventional cardiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debulging with the orbital atherectomy system (Diamondback 360®) | Experimental | Device: Debulging approach using the orbital atherectomy system |
| Debulging with various available methods | Active comparator | Procedure: Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 Years
- Chronic coronary syndrome with a clinical indication for percutaneous coronary intervention of a severely calcified lesion as defined by coronary computer tomography (CT; Agatston Score of target lesion ≥453 OR Calcium Arc >270°). The determination of calcification in the target lesion is based on native and contrast enhanced CT scans that are conducted as per clinical guidelines. The CT images must not be older than 6 months at the time of patient enrollment.
- Signed informed consent
- The patient is an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy
Key exclusion criteria (15 listed)
- Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours
- Cardiogenic shock
- Chronic total occlusion of the target lesion
- Glomerular filtration rate < 30 ml/min/1.73 m2
- Known presence, at the time of enrollment, of any contraindications listed in the Instructions for Use (IFU) of the investigational device:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debulging approach using the orbital atherectomy systemA uniform approach using only the orbital atherectomy system (Diamondback 360®), which sands away the calcium with a rotating crown | Device | Debulging with the orbital atherectomy system (Diamondback 360®) |
| Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapyA tailored approach, where the operator chooses from various available methods based on the patient's specific type of calcium | Procedure or surgery | Debulging with various available methods |
Primary outcome
Post-procedural Minimal Stent Area (MSA %) as assessed by optical coherence to-mography (OCT) imaging
Time frame: MSA will be assessed in the final OCT run performed after stent implantation withine baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for Orbital Atherectomy
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Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
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Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
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Lower Silesian Orbital Atherectomy Registry (LOAR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jelena Weller contact
Marco Ochs, PD Dr. principal investigator
Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debulging approach using the orbital atherectomy system and Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy in people with Orbital Atherectomy, run by IHF GmbH - Institut für Herzinfarktforschung at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcel Kunadt, Dr. (+49 621 59577 223, orfita@ihf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-procedural Minimal Stent Area (MSA %) as assessed by optical coherence to-mography (OCT) imaging (time frame: MSA will be assessed in the final OCT run performed after stent implantation withine baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.