Intek Apollo Paclitaxel Eluting coronary stent study

Clinical success and safety of Intek Apollo coronary drug eluting stent with paclitaxel release in patients with de novo lesion

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000594

Enrollment

100

Registered

2009-08-11

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

None listed

Interventions

Intervention1: Intek Apollo Paclitaxel eluting stents: Drug Eluting Stents Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient is a candidate for P.C.I (Percutaneous Coronary Intervention) as a definite treatment plan irrespective of his screen protocol 2. Patients eligible for coronary revascularization (angioplasty and / or CABG) 3.De novo lesion(s) 2.0 - 4.0 mm diameter , >= 5 mm and <=34 mm length in one or more coronary arteries. 4. The initial lesion is anticipated to be covered with one single stent. 5. Patient willing to comply with the informed consent and follow up. 6. The patient is hemodynamically stable before the procedure.

Exclusion criteria

Exclusion criteria: 1. Vessels < 2.0 and > 4.0 mm in diameter 2. Significant (>50%) stenosis proximal or distal to the target lesion that can not be treated in the same setting and may impede adequate coronary blood flow. 3. Calcified lesion that cannot be succesfully predilated 4. Target Lesion has excessive tortuousity , which makes it unsuitable for stent delivery and deployment. 5. Known allergies to aspirin, clopidogrel , ticlopidine or heparin. 6. Known platelet thrombocytopenia (<100,000/mm3)or s history of heparin - induced thrombocytopenia.

Design outcomes

Primary

Measure	Time frame
1. Clinical success (clinical device and clinical procedure) 2. Absence of ischemia driven MACE (Major Adverse Caediac Events) at 30 and 180 days. 3. Abscence of any ischemia driven target vessel failure (TVF) at 30 and 180 days. 4. Angiographic follow up at 180 daysTimepoint: 30 and 180 days	—

Secondary

Measure	Time frame
1. Abscence of ischemia driven target lesion revascularization (TLR) at 30 and 180 days. 2. Abscence of ischemia driven target vessel revascularization (TVR) at 30 and 180 days.Timepoint: 30 and 180 days	—

Countries

India

Contacts

Public ContactDr. Manoj Naik / Mr. Manoj Prabhu

balagopal.nair@piramal.com02239536910

Outcome results