A Clinical Trial To Study The Result Of Calcified Arteries Of The Heart Treated With Rotablation And Drug Eluting Stents With The Use Of Intravascular Imaging

One Year Clinical Outcome Of Calcified Obstructive Coronary Artery Disease Treated With Rotablation And Drug Eluting Stent With The Use Of Intravascular Imaging

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027130

Enrollment

50

Registered

2020-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Interventions

Intervention1: Rotablation Coronary Angiography and Stenting with Drug Eluting Stent : 1.Rotablation Frequency-160000 to 180000 rpm for burr less than 2 mm and 140000 to 160000 rpm for burr more th

Sponsors

PGIMER Chandigarh

Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Symptomatic ischemic heart disease with moderate to severe coronary calcified lesions not suitable for conventional PCI

Exclusion criteria

Exclusion criteria: Saphenous vein graft lesions Intacoronary thrombus Intracoronary dissections Severe three vessel disease Unprotected left main disease Lesion angulations in excess of 45Ë? Poor flow in distal coronary bed Sole remaining vessel

Design outcomes

Primary

Measure	Time frame
MACE (Major Adverse Cardiovascular Events) as defined by death, MI and TLR, either percutaneous or surgicalTimepoint: 1 year	—

Secondary

Measure	Time frame
Stent restenosis Stent thrombosis TVRTimepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Soumitra Ghosh

Post Graduate Institution Of Medical Education And Research (PGIMER, Chandigarh)

rajeshvijay999@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026