Predilation of Side Branch During Percutaneous Treatment... | NCT01090856

Studies
Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting

NCT01090856

Sponsor

Fundación Pública Andaluza Progreso y Salud

Status

Completed

Last Update Posted

Dec 5, 2014Estimated

Enrollment

420Actual

Phase

Phase 4

Conditions

Coronary Angiography

Interventions

Pre-dilation side branch

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Nov 2012Actual

Completion Date

May 2013Actual

First Submitted Date

Mar 22, 2010

First Submission Date that Met QC Criteria

Mar 22, 2010

First Posted Date

Mar 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2014

Last Update Posted Date

Dec 5, 2014Estimated

Name	Class
Hospital Universitario Reina Sofia de Cordoba	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation.

Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate and incidence of complications in patients with and without side-branch pre-dilation, as well as economic impact in terms of number of used wires.

Detailed Description

Introduction: Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation.

Design: Prospective and randomized study. Patients and methods: The series is constituted by 420 patients with bifurcations lesions that will be treated with drug-eluting stents; 210 patients will be treated with side branch pre-dilation before main vessels stent implantation, while the remaining 210 patients will be randomized to no pre-dilation of the side-branch.

Primary end point:

TIMI flow at Side Branch after main vessel stent implantation.

Secondary end points:

Time of re-wiring.
Number of used wires.
% of stenosis at Side Branch.
Levels of CK and TpI after the procedure.
Related cardiac events at 9 months. Relevance: Currently there has been controversy over the use of the side branch pre-dilation in patients with bifurcations lesions treated with provisional T-stenting. However, we have no comparative study in the literature.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

420Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No pre-dilation side branch	No Intervention
Pre-dilation side branch	Active Comparator		Procedure: Pre-dilation side branch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pre-dilation side branch	Procedure	Balloon pre-dilation of the side branch to facilitate the ulterior wire access.	Pre-dilation side branch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Side branch coronary flow after main vessels stent implantation		Immediately after catheterization procedure

Secondary Outcomes

Measure	Description	Time Frame
Time required for rewiring of the side branch		Inmediately after catheterization procedure
Number of used wires		Inmediately after catheterization procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with atherosclerotic coronary disease and bifurcation lesions an significant stenosis of the side branch.
Main vessels diameter greater than 2.5 mm in diameter at the operator's visual estimate.
The side branch should exceed 2.25 mm in diameter at the operator's visual estimate.
Patients with damage to the main branch of any length and the side branch lesions smaller than 5 mm in length.
Patients with bifurcation lesions fulfilling the following morphologies of the classification of Medina: 1 1 1, 1 0 1, 0 1 1.
Treatment of bifurcation lesions with previsional drug eluting stents.
Symptoms of stable angina or acute coronary syndrome.

Exclusion Criteria:

Contraindication to drug eluting stent implantation.
Cardiogenic shock.
Coexistence of other serious systemic diseases.
Patients in whom it is impossible to guide placement in the side branch before stent implantation in the main vessel.
Patients with bifurcation lesions and side branch less than 2 mm.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel Pan Alvarez-Osorio, MD	Hospital Universitario Reina Sofia de Cordoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Reina Sofía		Córdoba	Córdoba	14004	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7872167	Background	Pan M, Medina A, Suarez de Lezo J, Romero M, Melian F, Pavlovic D, Hernandez E, Segura J, Marrero J, Torres F, et al. Follow-up patency of side branches covered by intracoronary Palmaz-Schatz stent. Am Heart J. 1995 Mar;129(3):436-40. doi: 10.1016/0002-8703(95)90264-3.
10235088	Background	Pan M, Suarez de Lezo J, Medina A, Romero M, Hernandez E, Segura J, Castroviejo JR, Pavlovic D, Melian F, Ramirez A, Castillo JC. Simple and complex stent strategies for bifurcated coronary arterial stenosis involving the side branch origin. Am J Cardiol. 1999 May 1;83(9):1320-5. doi: 10.1016/s0002-9149(99)00093-4.