Coronary Artery DiseasePhase 4LISAIINCT01375855
Late Incomplete Stent Apposition Evaluation II: Comparison Between Polimer-based and No-polimer Stent System. IVUS Based Study
A Phase 4 study testing Percutaneous transluminal Coronary Angioplasty in people with Coronary Artery Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous transluminal Coronary Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2007to not given
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia.
- The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent
- Target Vessel diameter must be between 2.25- 4 mm with QCA.
- Patients must sign informed consent
- Patients and their physician must accept the angiographic follow-up
Who cannot join
- 18 years old patients
- SCA within the last 72 hours, or patients with CK twice over the upper normal limit
- Pregnancy
- Target vessel diameter < 2.25 or > 4 mm by QCA
- Previous brakitherapy or DES in the target lesion
- Restenotic lesion
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- -Allergy to aspirin, clopidogrel or ticlopidin
- Patients enrolled in other studies or trials
- By-pass graft lesions
- Real bifurcationa lesions
- Severe Renal insufficiency (creatinin clearance < 30 ml/min).
- Severe Liver failure(GOT y GPT > 3 times the upper normal limit)
- Life expectancy < 1 year because of other pathologies
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu y Sant Pau
Barcelona, Spain, 08025
Manel sabate, MD, PhD, 0034935565851, msabatet@santpau.es
Clarissa Cola, MD, 0034935565851, clarissacola@gmail.com
About this study
Official title: Late Incomplete Stent Apposition Evaluation II: Vascular Effects Evaluation After Polimer and No-polimer Based Coronary Artery Drug Eluting Stent Ilmplantation. An IVUS Based Study
Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site.
This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous transluminal Coronary Angioplasty
- Keywords
- Late stent malapposition, stent thrombosis, IVUS, non-polimeric stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous transluminal Coronary AngioplastyProcedure or surgery
Coronary artery stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Polimeric-PES | Active comparator | Arm receiving polimeric stent (Taxus) Receives: Procedure: Percutaneous transluminal Coronary Angioplasty |
| Non-Polimeric PES | Active comparator | Arm receiving non-polimeric PES (axxion) Receives: Procedure: Percutaneous transluminal Coronary Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra coronary ultrasound analysis to verify stent malapposition at follow-up
Measured: 9 months
Secondary outcomes (1)
Clinical events (myocardial infarction, TLR,at 1, 9, 12, 24 months follow-up:; Incidence of restenosis with QCA at 9 months follow-up Intimal hiperplasia measured by IVUS at 9 months follow-up; Stent Thrombosis.
Measured: 9 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Investigators
- Manel Sabate, MD, PhD, Principal investigator, Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375855
- Sponsor's protocol ID
- 2007-000142-12
- Acronym
- LISAII
- Status last verified
- Feb 2007
- First submitted
- 28 Dec 2010
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hong MK, Mintz GS, Lee CW, Park DW, Lee SW, Kim YH, Kang DH, Cheong SS, Song JK, Kim JJ, Park SW, Park SJ. Impact of late drug-eluting stent malapposition on 3-year clinical events. J Am Coll Cardiol. 2007 Oct 9;50(15):1515-6. doi: 10.1016/j.jacc.2007.07.038. Epub 2007 Aug 27. No abstract available.
PubMed 17919574Shiratori Y, Cola C, Brugaletta S, Alvarez-Contreras L, Martin-Yuste V, del Blanco BG, Ruiz-Salmeron R, Diaz J, Pinar E, Marti V, Garcia-Picart J, Sabate M. Randomized comparison between polymer-free versus polymer-based paclitaxel-eluting stent: two-year final clinical results. Circ Cardiovasc Interv. 2014 Jun;7(3):312-21. doi: 10.1161/CIRCINTERVENTIONS.113.000800. Epub 2014 May 6.
PubMed 24803435
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Incomplete Stent Apposition Evaluation II: Vascular Effects Evaluation After Polimer and No-polimer Based Coronary Artery Drug Eluting Stent Ilmplantation. An IVUS Based Study
- ClinicalTrials.gov ID
- NCT01375855
- Acronym / sponsor ID
- LISAII / 2007-000142-12
- Conditions
- Coronary Artery Disease
- Keywords
- Late stent malapposition, stent thrombosis, IVUS, non-polimeric stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Oct 2007
- First posted
- 17 Jun 2011 (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.
Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site.
This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polimeric-PES | Active comparator | Procedure: Percutaneous transluminal Coronary AngioplastyArm receiving polimeric stent (Taxus) |
| Non-Polimeric PES | Active comparator | Procedure: Percutaneous transluminal Coronary AngioplastyArm receiving non-polimeric PES (axxion) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia.
- The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent
- Target Vessel diameter must be between 2.25- 4 mm with QCA.
- Patients must sign informed consent
- Patients and their physician must accept the angiographic follow-up
Key exclusion criteria (13 listed)
- 18 years old patients
- SCA within the last 72 hours, or patients with CK twice over the upper normal limit
- Pregnancy
- Target vessel diameter < 2.25 or > 4 mm by QCA
- Previous brakitherapy or DES in the target lesion
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 |
|---|---|---|
| Percutaneous transluminal Coronary AngioplastyCoronary artery stent implantation | Procedure or surgery | Non-Polimeric PES, Polimeric-PES |
Primary outcome
Intra coronary ultrasound analysis to verify stent malapposition at follow-up
Time frame: 9 months
1 secondary outcome
Clinical events (myocardial infarction, TLR,at 1, 9, 12, 24 months follow-up:; Incidence of restenosis with QCA at 9 months follow-up Intimal hiperplasia measured by IVUS at 9 months follow-up; Stent Thrombosis.
Time frame: 9 months and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
- Background: PubMed 17919574Hong MK, Mintz GS, Lee CW, Park DW, Lee SW, Kim YH, Kang DH, Cheong SS, Song JK, Kim JJ, Park SW, Park SJ. Impact of late drug-eluting stent malapposition on 3-year clinical events. J Am Coll Cardiol. 2007 Oct 9;50(15):1515-6. doi: 10.1016/j.jacc.2007.07.038. Epub 2007 Aug 27. No abstract available.
- Derived from this study: PubMed 24803435Shiratori Y, Cola C, Brugaletta S, Alvarez-Contreras L, Martin-Yuste V, del Blanco BG, Ruiz-Salmeron R, Diaz J, Pinar E, Marti V, Garcia-Picart J, Sabate M. Randomized comparison between polymer-free versus polymer-based paclitaxel-eluting stent: two-year final clinical results. Circ Cardiovasc Interv. 2014 Jun;7(3):312-21. doi: 10.1161/CIRCINTERVENTIONS.113.000800. Epub 2014 May 6.
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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.
Manel Sabate, MD, PhD principal investigator
Hospital de la Santa Creu Y Sant Pau, Unidad de Hemodinamica
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 Percutaneous transluminal Coronary Angioplasty in people with Coronary Artery Disease, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Jun 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manel Sabate, MD, PhD (0034935565851, msabatet@santpau.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra coronary ultrasound analysis to verify stent malapposition at follow-up (time frame: 9 months). 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 NCT01375855, which also lists 2 linked publications.
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 17 Jun 2011.