| CTRI Number |
CTRI/2021/09/036701 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Long term safety of ultra-long 48mm stents |
|
Scientific Title of Study
|
Immediate procedural safety and long-term efficacy of Ultra-long 48 mm Xience-Xpedition stents: A real world experience from India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagendra Boopathy S |
| Designation |
Associate Professor Cardiology |
| Affiliation |
SRIHER |
| Address |
Department of Cardiology Sri Ramachandra Institute of Higher Education And
Research.
Porur
Chennai - 600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
7358560284 |
| Fax |
|
| Email |
drsnboopathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendra Boopathy S |
| Designation |
Associate Professor Cardiology |
| Affiliation |
SRIHER |
| Address |
Department of Cardiology Sri Ramachandra Institute of Higher Education And
Research.
Porur
Chennai - 600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
7358560284 |
| Fax |
|
| Email |
drsnboopathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagendra Boopathy S |
| Designation |
Associate Professor Cardiology |
| Affiliation |
SRIHER |
| Address |
Department of Cardiology Sri Ramachandra Institute of Higher Education And
Research.
Porur
Chennai - 600116.
Chennai
TAMIL NADU
600116
India |
| Phone |
7358560284 |
| Fax |
|
| Email |
drsnboopathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology, SRIHER |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
SRIHER |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Nagendra Boopathy |
Sri Ramachandra Institute of Higher Education and Research |
Department of Cardiology, Sri Ramachandra Institute of Higher Education And
Research.
Porur
Chennai - 600116.
Chennai
TAMIL NADU |
7358560284
drsnboopathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z988||Other specified postprocedural states, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who underwent percutaneous coronary intervention using
Xience Xpedition 48 mm long stent (Abbott vascular Santa Clara, CA ) who
will be willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Patients who will not give consent
Patients who could not be contacted |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major adverse cardiac events (MACE) – Death /MI/ reintervention |
follow up at least 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Death, MI, repeat revascularization, procedural success, clinical restenosis which is defined as target lesion revascularization or positive stress test in the intervened vessel or more than 50% in stent stenosis in the angiogram |
Follow up of at least 1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
04/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript submitted January 19, 2022, accepted February 28, 2022, published online April 5, 2022
Short title: Clinical Outcomes in Patients Receiving ULEES
doi: https://doi.org/10.14740/cr1357 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cardiovascular disease (CVD) is the leading cause of mortality in India. Percutaneous coronary intervention (PCI) is a commonly used treatment modality for patients with coronary artery disease. Drug eluting stents (DES) are more efficient than the bare metal stents. Long lesions require treatment with longer balloons and stents, leading to greater arterial injury, which might result in exaggerated neointimal hyperplasia. Long DES is also an independent risk factor for subsequent myocardial infarction, which maybe associated with increased mortality. longer lesions can be treated either overlapping of two shorter stents or placement of a single long stent. Current data indicate that both stent length and stent overlap are associated with major adverse cardiac events. Stent overlap has been associated with increased neointimal proliferation and lumen loss due to delayed healing and increased inflammation. New stent designs with increase length are emerging as an increasingly utilized tool in PCI. The longest stent, called ultra long stent, approved by the USFDA is 38mm. In India, 48mm Xience Xpedition (Abbott Vascular, Santa Clara, Calif) is DGCI approved. The Xience Xpedition 48 mm EES is a proprietary L-605 cobalt-chromium alloy stent pre-mounted on a rapid exchange delivery system. The abluminal surface of the device is coated in a thin layer of durable fluoropolymer, which is used as a carrier for Everolimus. There is no large data available studying the efficacy of stents greater than 38mm. We thereby sought to assess the immediate procedural success and long term efficacy and safety ultra long 48mm Xience xpedition stents in our study. |