An observational study to evaluate the results of coronary stent implantation in patients with complicated coronary artery disease using optical coherence tomography- a novel coronary imaging modality

Not Applicable

• Conditions: Health Condition 1: null- Complex coronary artery disease

• Registration Number: CTRI/2018/04/013445
• Lead Sponsor: Command Hospital Air Force Bangalore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects meeting ALL the below mentioned criteria would be included in the study:

1. Age 18-90 years.

2. Eligible for Coronary Revascularisation.

3. Diagnosis of CAD (either or both)

a. Angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, Ill, IV).

b. Diagnosis of ACS (STEMI as defined by Universal definition of myocardial infarction after window period, NSTEACS as defined by E Braunwald)

4. Target reference vessel diameter of lesions > 2.5mm and < 4.0mm in diameter (angiographic estimate).

5. Target lesion stenosis for lesions is > 50% and < 100% (visual estimate).

6. At least TIMI I coronary flow.

7. Complex lesion as defined as any one or more of the following

a. ACC/AHA lesion angiographic classification type B &C

b. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch >=2.5mm

.c. Chronic total occlusion (>=3 months) as target lesion

d. Unprotected left main (LM) disease (LM body, distal LM bifurcation)

e. Implanted stent length >=20mm

f. Multi-vessel PCI (>=2 major coronary arteries treated at one PCI session)

g. Multiple stent needed (>=3 more stent per patient)

h. In-stent restenosis lesion as target lesion

j. Severely calcified lesion (encircling calcium in angiography)

8. Willingness to comply with the specified follow-up evaluation.

9. Ability to provide written informed consent prior to the procedure using a form that is approved by the Ethics Committee.

Exclusion Criteria

1. Any history of bleeding diathesis or coagulopathy

2. ST-elevation acute myocardial infarction within window period

3. Known hypersensitive or contra-indicated to contrast agent, heparin, aspirin, clopidogrel , ticagrelor or prasugrel (that cannot be managed medically).

4. Azotemic patients with eGFR < 60 ml/min

5. Severe hemodynamic instability or shock

6. Bacteremia or sepsis

7. Diagnosis of coronary artery spasm/Prinzmetalâ??s angina

8. Pregnant or nursing

9. Unprotected ostial left main or ostial right coronary artery disease (stenosis >50%).

10. Significant ( > 50%) stenosis proximal or distal to the target lesionS.

11. Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated and/or an excessively tortuous vessel which makes it unsuitable for stent delivery and deployment.

12. Cerebrovascular Accident (CVA) within the past 6 months.

13. Target lesion located in a bypass graft.

14. Participated in an investigational drug or device study in the past 3 months.

15. Intervention of another lesion within 30 days prior to, or is planned or highly probably to be performed 30 days after the index procedure

16. Unwilling for informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of sub optimal stent deploymentTimepoint: Immediately after the procedure

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac EventsTimepoint: 6 months;Procedure related complicationsTimepoint: within 72 hours