| CTRI Number |
CTRI/2019/05/019297 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
07/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Academic Study |
| Study Design |
Other |
|
Public Title of Study
|
An Optical Coherence Tomography Study of Sirolimus-eluting Stent in Patients with Diabetes Mellitus |
|
Scientific Title of Study
|
Vascular Response in Patients with Diabetes Mellitus: An Optical Coherence Tomography Study of Ultrathin Strut Biodegradable Polymer-coated Sirolimus-eluting Stent |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Cruz/DIAB/OCT/001, Version 1.0, Dated 03 April 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Abhyankar |
| Designation |
Clinical Director – Interventional Cardiology |
| Affiliation |
Shree B. D. Mehta Mahavir Heart Institute |
| Address |
Department of Cardiology, Athwagate, Ring Road,
Surat
GUJARAT
395001
India |
| Phone |
9824145738 |
| Fax |
|
| Email |
atulda.abhyankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Abhyankar |
| Designation |
Clinical Director – Interventional Cardiology |
| Affiliation |
Shree B. D. Mehta Mahavir Heart Institute |
| Address |
Department of Cardiology, Athwagate, Ring Road,
Surat
GUJARAT
395001
India |
| Phone |
9824145738 |
| Fax |
|
| Email |
atulda.abhyankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Abhyankar |
| Designation |
Clinical Director – Interventional Cardiology |
| Affiliation |
Shree B. D. Mehta Mahavir Heart Institute |
| Address |
Department of Cardiology, Athwagate, Ring Road,
Surat
GUJARAT
395001
India |
| Phone |
9824145738 |
| Fax |
|
| Email |
atulda.abhyankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sahajanand Medical Technologies Pvt. Ltd.,
Sahajanand Estate, Wakhariawadi, Near Dabholi, Ved Road, Surat – 395 004, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Universal Cardiovascular Research Foundation |
| Address |
205, C Tower, Abhishek Park,
Athwalines Road, Parle Point,
Surat - 395007, Gujarat, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Abhyankar |
Shree B. D. Mehta Mahavir Heart Institute |
Department of Cardiology, Athwagate, Ring Road, Surat-395001, Gujarat, India
Surat
GUJARAT |
9824145738
atulda.abhyankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree B. D. Mehta Mahavir Heart Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I209||Angina pectoris, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient must be at least 18 years of age
2. Patient with symptomatic coronary artery disease
3. Stable patients with diabetes mellitus
4. Only Supralimus Grace stent(s) is/are to be implanted into the coronary vasculature during the index procedure
5. Able to understand and sign the written informed consent form
6. Able and willing to follow the protocol requirements |
|
| ExclusionCriteria |
| Details |
1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure
2. Life expectancy <12 months due to another medical condition
3. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds
4. Creatinine level more than 2.0 mg/dL or ESRD
5. Severe hepatic dysfunction (more than 3 times normal reference values)
6. Planned surgery procedure ≤3 months post-index procedure
7. Known allergy to cobalt-chromium
8. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 3 months post index procedure
9. No suitable anatomy for OCT scan in the opinion of investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Strut-level analysis:
1. Proportion of covered struts
2. Thickness of neointimal hyperplasia (NIH) over covered struts
3. Proportion of malapposed struts
4. Mean malapposed strut-to-lumen distance
5. Ratio of uncovered struts to total struts (RUTTS)
6. Maximum length of consecutive segments of uncovered and malapposed struts
Cross-section level analysis:
1. NIH area, volume
2. Percent volumetric stent obstruction
3. Incomplete stent apposition (ISA) area and volume |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serial changes in mean lumen area, minimum lumen area, and ISA area from post-procedure to the assigned follow-up period |
3 Months |
Qualitative NIH assessment at follow-up:
- Proportion of cross-sections with peri-strut low intensity areas (PLIA) and neoatherosclerosis
- Quantification of NIH backscattering, attenuation, and optical intensity |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, single center, single-arm, investigator-initiated study. The objective of this study is to evaluate the completeness of struts coverage and vessel wall response at 3 months after implantation of Supralimus Grace sirolimus-eluting stent in patients with diabetes mellitus by optical coherence tomography (OCT) analysis.
OCT is a new light-based intracoronary imaging modality with unprecedented spatial resolution. Currently, its axial resolution is only 15 μm, that is, 10 times higher than that of more classical techniques such as intravascular ultrasound (IVUS) based on ultrasounds (150 μm). OCT therefore provides extremely high-quality images of the coronary wall, especially of the structures closest to the vessel lumen. OCT is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque, and neointimal proliferation. |