Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-24 @ 3:20 AM
Study NCT ID:
NCT02062593
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2014-01-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina
Sponsor:
Imperial College London
Organization:
Study Overview
Official Title:
Defining a Gold Standard for Ischaemia: Effects of Interventional Revascularisation Versus Optimum Medical Therapy on Exercise Capacity in Patients With Stable Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORBITA
Brief Summary:
In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.
Detailed Description:
The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: