NCT01426139

Brief Summary

The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

August 10, 2011

Last Update Submit

April 3, 2013

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • In-Stent Late Lumen Loss

    9 months post index procedure

Study Arms (1)

Biotronik Orsiro DES

EXPERIMENTAL
Device: Percutaneous Coronary Intervention Biotronik Orsiro DES

Interventions

Percutaneous Coronary Intervention Biotronik Orsiro DESDEVICE

Stenting

Biotronik Orsiro DES

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has provided a written informed consent
  • Single de novo lesion with ≥ 50% and \<100% stenosis in up to 2 coronary arteries
  • The target lesion length is ≤ 26 mm
  • The target reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm

You may not qualify if:

  • Evidence of myocardial infarction within 72 hours prior to index procedure
  • Unprotected left main coronary artery disease (stenosis \>50%)
  • Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
  • Target lesion involves a side branch \> 2.0 mm in diameter
  • Heavily calcified lesion
  • Target lesion is located in or supplied by an arterial or venous bypass graft

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Madras Medical Mission

Chennai, 600037, India

Location

Medanta The Medicity Hospital

Gūrgaon, 122001, India

Location

Max Super Speciality Hospital

New Delhi, 110017, India

Location

Fortis Escorts Heart Institute and Research Centre

New Delhi, 110025, India

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 31, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

IN(4)