NCT00914979

Brief Summary

Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
terminated

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

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

2.9 years

First QC Date

June 4, 2009

Last Update Submit

June 21, 2015

Conditions

Bifurcation Coronary Disease

Keywords

AngiosculptBifurcation LesionSide branchIVUS

Outcome Measures

Primary Outcomes (1)

  • Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE

    9 Months

Secondary Outcomes (4)

  • Rate of side branch stenting

    9 Months

  • Angiographic dissection rate and grade

    9 months

  • MACE rate at 30 days post-procedure

    9 months

  • Cumulative stent thrombosis and TLR rates at 9 months

    9 months

Study Arms (1)

1

EXPERIMENTAL

Single Arm - Interventional

Device: AngioSculpt

Interventions

AngioSculptDEVICE

The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip

1

Eligibility Criteria

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

You may qualify if:

  • Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).

You may not qualify if:

  • Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
  • Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Khalid Suleiman

Afula, 18101, Israel

Location

Oded Izenberg

Rehovot, Israel

Location

Alexander Goldberg

Safed, Israel

Location

Ricardo Krakover

Zrifin, Israel

Location

Study Officials

  • Khalid Suleiman, MD

    Heart Institute; Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 5, 2009

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

IL(4)