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Clinical Trials/CTRI/2024/07/069759
CTRI/2024/07/069759Not yet recruitingPhase 4

Comparison of outcomes of drug coated balloon angioplasty and plain old balloon angioplasty of ostial coronary lesions

VMMC and Safdarjung hospital1 site in 1 country60 target enrollmentStarted: July 10, 2024Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Angiographic outcomes:
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Thus study is a randomized parallel group trial comparing Drug coated balloon (DCB) angioplasty and Plain Old Balloon Angioplasty (POBA) for ostial coronary lesions. This study will be conducted in Department of Cardiology, VMMC and Safdarjung Hospital, New Delhi. 60 patients undergoing PCI with intention to use balloon only strategy for de novo side branch ostial lesion (Medina 0,0,1) meeting inclusion criteria will be included.  The patients will be followed up after a period of 6 months. Primary (angiographic) and secondary (clinical) outcomes will be assessed at follow-up.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Stable angina with documented ischemia or typical symptoms with ECG changes or Unstable angina
  • •Eligible for PCI with the intention to use balloon only strategy for de novo side branch ostial lesion (Medina classification 0,0,1)
  • •Side branch with diameter greater than 2.0mm.

Exclusion Criteria

  • •Left main bifurcation except isolated ostial LCX lesion.
  • •If angioplasty of any other lesion is required/ performed with study procedure.
  • •Severely calcified lesions
  • •Contraindications to DAPT
  • •History of hypersensitivity to contrast
  • •Prior stenting in target vessel.

Outcomes

Primary Outcomes

Angiographic outcomes:

Time Frame: Procedural and 6 month follow up

1. Minimum lumen diameter (MLD)

Time Frame: Procedural and 6 month follow up

2. Percentage of diameter stenosis

Time Frame: Procedural and 6 month follow up

3. Percentage of area stenosis

Time Frame: Procedural and 6 month follow up

4. Acute luminal gain

Time Frame: Procedural and 6 month follow up

5. Late lumen loss

Time Frame: Procedural and 6 month follow up

6. Loss index

Time Frame: Procedural and 6 month follow up

Secondary Outcomes

  • 1. In hospital and short term composite MACE(2. Death)

Investigators

Sponsor
VMMC and Safdarjung hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Asmita Gupta

VMMC and Safdarjung Hospital

Study Sites (1)

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