Coronary Health DiseasePhase 4NCT02516891
Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Stereoscopic Microscopy Study
A Phase 4 study testing Drug-Eluting Stents implantation in bifurcation lesions in people with Coronary Health Disease, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval maneuvers after the jailing. 2) To determined anatomic and technical factors influencing the induced damage in the guidewire. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Health Disease
- What is being tested?
- Drug-Eluting Stents implantation in bifurcation lesions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with atherosclerotic coronary disease and bifurcation lesions requiring protection with side branch.
- The art of imprisoned guide.
- The main branch should be greater than 2.5 mm in diameter at the operator's visual estimate.
- The side branch must exceed 2 mm in diameter or have sufficient authority to protect the operator decides with a guide for the release of the main vessel stent.
- Patients with the above characteristics and main or side branch of any length.
- Patients with bifurcation lesions with any morphology of the Medina classification: 1 1 1 1 0 1 0 1 1, 110, 001, 010, 100.
- Treatment of bifurcation with any technique and any type of stent in the side branch meets the criteria above.
- Symptoms of stable angina or acute coronary syndrome.
Who cannot join
- Patients with collateral bouquet of little significance.
- Patients in cardiogenic shock.
- Patients in whom it is impossible to guide the placement of the side branch before implantation in the glass principal.
- Patients who do not give their consent for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Prospective Randomized Study With Stereoscopic Microscopy
The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval maneuvers after the jailing.
- To determined anatomic and technical factors influencing the induced damage in the guidewire.
Design of the study: prospective randomized study to compare 2 types of guidewire: hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation coronary lesions will be included. All of then will be treated by provisional side-branch stenting using the jailed wire technique. One hundred patients will be randomized to hydrophilic wires and another 100 patients to non-hydrophilic wires.
Read the detailed description
The percutaneous approach of bifurcation lesions is a complex procedure; when the stent is implanted at main vessel, a closure of the side-branch may occur. The re-wiring of the side-branch in these conditions may be difficult or even impossible. To facilitate the re-wiring maneuvers the operators use the jailed wired technique. For this technique a guide-wire is introduced in the side-branch before main vessel stent implantation; after the stent deployment the wire remains jailed between the vessel wall and the metallic structure of the stent. If the side-branch became occluded, this wire is a good landmark of it is position, facilitating the access with a new wire. However, the rupture of the wire has been described in some cases, during the retrieval maneuvers.
- Conditions
- Coronary Health Disease
- Being tested
- Drug-Eluting Stents implantation in bifurcation lesions
- Keywords
- treatment, stent, coronary bifurcations lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Eluting Stents implantation in bifurcation lesionsDevice
| Study group | Role | What they receive |
|---|---|---|
| hydrophilic wire/Drug-Eluting Stents | Experimental | Will include 100 patients with coronary bifurcation lesions in that they will be treated with stents and in which the technique is used jailed guide. Receives: Device: Drug-Eluting Stents implantation in bifurcation lesions |
| Non hydrophilic wire/Drug-Eluting Stents | No intervention | Will include 100 patients with coronary bifurcation lesions in that they will be treated with stents and in which the technique is used jailed guide.non hydrophilic guide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
No damage: the guidewire suffered no loss of integrity over its entire length
Measured: 3 years
Slight damage: the external cover suffered loss of integrity < 2 mm
Measured: 3 years
Moderate damage: the external cover suffered loss of integrity > 2 mm
Measured: 3 years
Severe damage: visible changes to the inner cover of the guidewire.
Measured: 3 years
Fracture: discontinuity at some point along the guidewire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startFeb 2012
- Primary completionJun 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Health DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516891
- Sponsor's protocol ID
- PI12/00440
- Status last verified
- Apr 2016
- First submitted
- 23 Jul 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pan M, Ojeda S, Villanueva E, Chavarria J, Romero M, Suarez de Lezo J, Mazuelos F, Segura J, Carrasco F, Hidalgo F, Lopez Aguilera J, Rodriguez S, Puente M, Suarez de Lezo J. Structural Damage of Jailed Guidewire During the Treatment of Coronary Bifurcation Lesions: A Microscopic Randomized Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1917-24. doi: 10.1016/j.jcin.2016.06.030.
PubMed 27659568
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Prospective Randomized Study With Stereoscopic Microscopy
- ClinicalTrials.gov ID
- NCT02516891
- Acronym / sponsor ID
- PI12/00440
- Conditions
- Coronary Health Disease
- Keywords
- treatment, stent, coronary bifurcations lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Feb 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval maneuvers after the jailing.
- To determined anatomic and technical factors influencing the induced damage in the guidewire.
Design of the study: prospective randomized study to compare 2 types of guidewire: hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation coronary lesions will be included. All of then will be treated by provisional side-branch stenting using the jailed wire technique. One hundred patients will be randomized to hydrophilic wires and another 100 patients to non-hydrophilic wires.
Detailed description
The percutaneous approach of bifurcation lesions is a complex procedure; when the stent is implanted at main vessel, a closure of the side-branch may occur. The re-wiring of the side-branch in these conditions may be difficult or even impossible. To facilitate the re-wiring maneuvers the operators use the jailed wired technique. For this technique a guide-wire is introduced in the side-branch before main vessel stent implantation; after the stent deployment the wire remains jailed between the vessel wall and the metallic structure of the stent. If the side-branch became occluded, this wire is a good landmark of it is position, facilitating the access with a new wire. However, the rupture of the wire has been described in some cases, during the retrieval maneuvers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrophilic wire/Drug-Eluting Stents | Experimental | Device: Drug-Eluting Stents implantation in bifurcation lesionsWill include 100 patients with coronary bifurcation lesions in that they will be treated with stents and in which the technique is used jailed guide. |
| Non hydrophilic wire/Drug-Eluting Stents | No intervention | –Will include 100 patients with coronary bifurcation lesions in that they will be treated with stents and in which the technique is used jailed guide.non hydrophilic guide. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with atherosclerotic coronary disease and bifurcation lesions requiring protection with side branch.
- The art of imprisoned guide.
- The main branch should be greater than 2.5 mm in diameter at the operator's visual estimate.
- The side branch must exceed 2 mm in diameter or have sufficient authority to protect the operator decides with a guide for the release of the main vessel stent.
- Patients with the above characteristics and main or side branch of any length.
Key exclusion criteria (4 listed)
- Patients with collateral bouquet of little significance.
- Patients in cardiogenic shock.
- Patients in whom it is impossible to guide the placement of the side branch before implantation in the glass principal.
- Patients who do not give their consent for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-Eluting Stents implantation in bifurcation lesions | Device | hydrophilic wire/Drug-Eluting Stents |
Primary outcome
No damage: the guidewire suffered no loss of integrity over its entire length
Time frame: 3 years
Slight damage: the external cover suffered loss of integrity < 2 mm
Time frame: 3 years
Moderate damage: the external cover suffered loss of integrity > 2 mm
Time frame: 3 years
Severe damage: visible changes to the inner cover of the guidewire.
Time frame: 3 years
Fracture: discontinuity at some point along the guidewire
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 27659568Pan M, Ojeda S, Villanueva E, Chavarria J, Romero M, Suarez de Lezo J, Mazuelos F, Segura J, Carrasco F, Hidalgo F, Lopez Aguilera J, Rodriguez S, Puente M, Suarez de Lezo J. Structural Damage of Jailed Guidewire During the Treatment of Coronary Bifurcation Lesions: A Microscopic Randomized Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1917-24. doi: 10.1016/j.jcin.2016.06.030.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug-Eluting Stents implantation in bifurcation lesions in people with Coronary Health Disease, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No damage: the guidewire suffered no loss of integrity over its entire length (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.