Investigator initiated retrospective observational study to determine safety and performance of NeohexaÂ® Rapamycine (Sirolimus)-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one year follow-up period.

Neo-Registry :Observational retrospective study to Determine safety and performance of (NeoHexa)Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one year follow-Up Period"

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/03/012522

Enrollment

129

Registered

2018-03-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: null- coronary artery disease (CAD)

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and Females more than 18 years of age. 2. Subjects who had signed the Hospital consent form. 3. The subjects who have been treated with PCI and implantated with Neohexa Drug Eluting Stent as a part of their treatment of Coronary Artery Disease, without any further indication for Emergent Coronary Artery Bypass Graft Surgery.

Exclusion criteria

Exclusion criteria: 1.Subjects who were not eligible for a PCI procedure. Or who were candidates for Urgent or planned elective Coronary Artery Bypass Surgery. 2. Subjects who are treated with stents other than Neohexa stent. 3. Subjects who are known sensitive to Cobalt Chromium alloy,PLLA Polymer, Sirolimus and its Analogues, Aspirin, Clopidogrel and analogues, and Contrast media. 4. Pregnant/lactating women during Index procedure. However,if pregnancy occurs during followâ??ups, the subject will not be excluded. 5. Subjects with more than Grade III Renal Insufficiency as indicated by Creatinine > 160 mcmol/L. 6. Subjects with short life expectancy less than the trial duration of 1 years (including patients with cancer, HIV/AIDS),documented LVEF heart disease, Myocardiopathies, Arrhythmia or other Comorbid conditions.

Design outcomes

Primary

Measure	Time frame
To evaluate major adverse cardiac event (MACE) at 6 month defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR).Timepoint: 6 Month	—

Secondary

Measure	Time frame
1. Target Lesion Revascularization at 1,6 and 12 months. 2. Major Adverse Cardiac Events at 1,6 and 12 months. 3. Frequency of Stent Thrombosis a. Acute (0â??48 hours after stent implant) b. Late (1 month to 1 year after stent implant) c. Very Late (Beyond 1 year after stent Implant) d. By ARC definitions: Viz. Definite, Probable and Possible, at all follow up visits.Timepoint: 1month 6month 12, month	—

Measure

Time frame

1. Target Lesion Revascularization at 1,6 and 12 months. 2. Major Adverse Cardiac Events at 1,6 and 12 months. 3. Frequency of Stent Thrombosis a. Acute (0â??48 hours after stent implant) b. Late (1 month to 1 year after stent implant) c. Very Late (Beyond 1 year after stent Implant) d. By ARC definitions: Viz. Definite, Probable and Possible, at all follow up visits.Timepoint: 1month 6month 12, month

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Countries

India

Contacts

Public ContactDr Rajagopal J

Cauvery Heart & MultiSpeciality Hospital

rajagopalj@gmail.com9980298321

Outcome results