Coronary Intervention Using the CardioMind Coronary Stent System for the treatment of stenotic lesions in small diameter native coronary arteries

A prospective, randomized, multicenter study to evaluate the safety, efficacy and performance of the CardioMind Coronary Stent Systems for treatment of stenotic lesions in small diameter native coronary arteries.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000578404

Acronym

CARE II

Enrollment

230

Registered

2007-11-09

Start date

2008-01-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The study will enroll 230 patients in a randomized evaluation of a new stent delivery system developed for use in small coronary arteries. The study device is designed with a low profile, maneuverable delivery system to reach small, distal lesions. This study is designed to show that the new stents are safe and effective when compared to the comparator, commercially-available stent. Follow-up will occur at 30 days, 6, 8, and 12 month intervals for the first year, then annually for the next four years.

Interventions

The study will randomize 230 patients with de novo lesions in native coronary arteries with a reference diameter of 2.0 – 2.75 mm. The 3 treatment arms include the CardioMind sirolimus-eluting stent, the CardioMind bare metal stent, and the Medtronic Micro-Driver bare metal stent. Clinical follow-up will occur at 30 days, 8, 12 and 24 months. Telephone follow-up will occur at 6 months and years 3-5. Data will be compared among treatment groups.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Suitable candidate for percutaneous coronary intervention (PCI) in a symptomatic native coronary vessel with a reference diameter of 2.0 – 2.75 mm and lesion length < 20 mm. Treatment of one non-target lesion in a separate epicardial vessel is allowed.

Exclusion criteria

Need for treatment of a second lesion in the target vessel 30 days before or after the index procedure, excessive calcification or tortuosity, presence of thrombus or Thrombolysis in Myocardial Infarction (TIMI) flow < 2, concomitant health conditions (renal insufficiency, recent stroke, myocardial infarction (MI) or gastrointestinal (GI) bleeding), pregnant, unable to comply with antiplatelet therapy, ostial lesions, low coronary reserve.

Outcome results