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Studying outcomes of Calcium modifying device in Severely Calcified Coronary Arteries Under guidance of Imaging

Prospective, Multicenter, Observational Study to Evaluate Clinical Outcomes of Orbital Atherectomy in Severely Calcified Coronary Arteries Under OCT Guidance - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096215
Enrollment
100
Registered
2025-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I25- Chronic ischemic heart disease Health Condition 2: I214- Non-ST elevation (NSTEMI) myocardial infarction Health Condition 3: I200- Unstable angina

Interventions

Intervention1: Nil: Nil

Sponsors

Dr Balbir Singh (Max Super Speciality Hospital)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender, aged 18 years and above 2. Patients presenting with any one of the conditions (SIHD/US/NSTEMI) 3. Patients willing to sign written informed consent Imaging Inclusion Criteria 1. Use of OCT guidance mandatory for all enrolled patients 2. The target lesion(s) is a de novo coronary lesion with stenosis more than equal to 50% and less than 100%, the reference vessel diameter of each target vessel more than or equal to 2.5 and less than 4.0mm at the lesion site 3. The target lesion has OCT evidence of severe calcium at the lesion site

Exclusion criteria

Exclusion criteria: 1. Patients with hemodynamic instability or cardiogenic shock 2. Patients with chronic total occlusion and In-stent restenosis lesions 3. Patients with a life expectancy of less than 1 year 4. Patients with contraindication for dual antiplatelet therapy (DAPT) 5. Patients who require the use of atherectomy devices, laser, or intravascular lithotripsy (IVL) other than OA in the target lesion 6. Patients unwilling to sign the informed consent Angiographic Exclusion criteria 1. The target lesion is located within a bypass graft 2. Angiographic evidence of thrombus 3. Angiographic evidence of significant dissection at the treatment site

Design outcomes

Primary

MeasureTime frame
Rate of Target vessel failure (TVF) defined as a composite of Target vessel myocardial infarction (TV-MI), Cardiovascular death and Target lesion revascularization (TLR)Timepoint: One Year—

Secondary

MeasureTime frame
1. Procedural Success 2. Clinical Success 3. MACETimepoint: 1. Baseline 2. Baseline 3. In-hospital, 30 days, 6 & 12 months—

Countries

India

Contacts

Public ContactDr Balbir Singh

Max Super Speciality Hospital

drbalbirs@gmail.com9818890479

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026