Coronary RestenosisPhase 4NCT00752362
Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)
A Phase 4 study testing Infinnium® and Supralimus® in people with Coronary Restenosis, run by Sahajanand Medical Technologies Limited at 11 sites in Brazil.
Trial summary
Objectives: PRIMARY OBJECTIVE: To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents. SECONDARY OBJECTIVES: Safety: To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1 year, 3 years and 5 years… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Restenosis
- What is being tested?
- Infinnium® and Supralimus®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 11 sitesBrazil
- Study dates
- Mar 2006to May 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia;
- De novo coronary lesion (non-restenosis);
- Target lesion located in a native artery;
- Target lesion located in a vessel with diameter between 2.5-3.5 mm (visual analysis);
- Target lesion amenable to treatment with a single stent of up to 29 mm in length;
Show all 9Show fewer
- Target lesion with a diameter stenosis > 50% (visual analysis);
- Acceptable candidate for surgical revascularization;
- Signed informed consent term.
Who cannot join
- GENERAL EXCLUSION CRITERIA
- Q-wave myocardial infarction < 48 hours before the index procedure
- Recent myocardial infarction, with or without Q waves, with cardiac markers levels still above the normal upper limits
- Left ventricle ejection fraction ≤30%
- Renal dysfunction (serum creatinine > 2.0 mg/dl [>177 µmol/l])
- Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3
Show all 29Show fewer
- White cell count < 3.000 cells/mm3
- Suspected or known liver disease (including subclinical hepatitis)
- Heart transplant recipient
- Know allergy to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin, or stainless steel
- Life expectancy < 12 months
- Any medical condition that, in the opinion of the investigator, may interfere with the ideal participation in study
- Current inclusion in another study to investigate drug or other device, or planned inclusion in another study to investigate drug or other device during the follow-up.
- Coronary angioplasty (with or without stent) < 6 months in any segment of the target vessel
- Previous coronary angioplasty (with or without stent), at any time, in a coronary segment < 5 mm (proximal or distal) from the target lesion
- Coronary angioplasty (with or without stent) in any segment of the target vessel planned during the next 12 months following the index procedure.
- ANGIOGRAPHIC EXCLUSION CRITERIA
- Restenotic target lesion
- Need for treatment of more than one lesion in the target vessel;
- Diameter of the target vessel < 2.5 mm or > 3.5 mm (visual analysis)
- Long target lesion, not amenable to treatment with a single stent of up to 29 mm in length, according to the operator's discretion
- Significant (> 50%) unprotected left main lesion
- Angiographic thrombus
- Target lesion located in bypass graft
- Occluded target vessel (antegrade flow TIMI 0 or 1)
- Target lesion in ostial location;
- Target lesion in a bifurcation site with a side branch > 2.5 mm or that may require stent implantation;
- Calcified target lesion with anticipated unsuccessful balloon pre-dilatation;
- Severely tortuous target vessel.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Hospital Biocor
Belo Horizonte, Minas Gerais, 34000-000
Hospital Universitário Walter Cantídio
Fortaleza, Ceará, 60430-370
Hospital Natal Center
Natal, Rio Grande do Norte, 59054-630
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Rede D'Or de Hospitais
Rio de Janeiro, Rio de Janeiro, 20941-150
Hospital São Paulo - UNIFESP
São Paulo, São Paulo, 04024-002
Hospital São Camilo
São Paulo, São Paulo, 05022-001
Hospital Santa Marcelina
São Paulo, São Paulo, 08270-070
Instituto do Coração - InCor
São Paulo, 05403-900
Hospital Universitário Cassiano Antonio de Moraes
Vitória, Espírito Santo, 29042-755
Hospital Meridional Intercath
Vitória, Espírito Santo, 29156-580
About this study
Official title: PercutAneous INTervention With Biodegradable- Polymer Based Paclitaxel-eluting, Sirolimus-eluting, or Bare Stents for the Treatment of de Novo Coronary Lesions.
Objectives:
PRIMARY OBJECTIVE:
Read more
To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
SECONDARY OBJECTIVES:
Safety:
To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the occurrence de Serious Adverse Events (SAEs) within 5 years among the paclitaxel, sirolimus and control study arms.
To compare the occurrence of in-stent thrombosis within 5 years among the paclitaxel, sirolimus and control study arms.
Efficacy:
To compare the rate of angiographic success among the study groups To compare the rate of procedural success among the study groups To compare the incidence of clinically driven target lesion revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the incidence of clinically driven target vessel revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the 1-year, 3-year and 5-year cost-effectiveness profile of the paclitaxel, sirolimus and control study arms.
To compare the 9-month in-stent late loss of paclitaxel-eluting stents to the in-stent late loss of sirolimus-eluting stents To compare the 9-month in-segment late loss among the study groups To compare the 9-month in-stent and in-segment binary restenosis rate among the study groups To compare the IVUS percent neointimal obstruction among the study groups
Study Design:
In the present RANDOMIZED study, the paclitaxel-eluting stent Infinnium® and the sirolimus-eluting stent Supralimus® will be compared to a metallic stent with the same structure (Milennium Matrix®) but without drug elution for the treatment of de novo lesions in native coronaries. The study will be a multicenter clinical trial and will include patients for the treatment with one of the three study stents. In total, 275 patients will be enrolled, randomly allocated for the Infinnium®, Supralimus®, or Milennium Matrix® stents in a 2:2:1 proportion. Patients will be followed-up for 12 months after the index procedure. All patients will undergo a follow-up angiography at 9 months. A subgroup of 55 patients will be evaluated at 9 months with IVUS examination.
Treatment:
Patients will be treated, according to the randomization groups, with Infinnium®, Supralimus®, or Milennium Matrix® stents of 19 mm, 23 mm, or 29 mm and nominal diameters of 2.5, 3.0, and 3.5 mm.
- Conditions
- Coronary Restenosis
- Being tested
- Milennium Matrix® (Control), Infinnium®, Supralimus®
- Keywords
- Supralimus®,, Infinnium®,, Matrix®,, Restenosis, Percutaneous, Revascularization, Techniques, Metallic, Platform, Agents, Antiproliferative, Properties
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milennium Matrix® (Control)Device
Also called Milennium Matrix®
Percutaneous coronary intervention with bare metal stent
Infinnium®Device
Percutaneous coronary intervention with paclitaxel-eluting stent
Supralimus®Device
Percutaneous coronary intervention with sirolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Percutaneous coronary intervention with bare metal stent Receives: Device: Milennium Matrix® (Control) |
| 2 | Experimental | Percutaneous coronary intervention with paclitaxel-eluting stent Receives: Device: Infinnium® |
| 3 | Experimental | Percutaneous coronary intervention with sirolimus-eluting stent Receives: Device: Supralimus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
Measured: 9 months
Secondary outcomes (1)
MACE at 1,9&12M, SAE & ST until 12M. Rate of angiographic & procedural success, TLR & TVR at 1&9M Instent LL between Supralimus®, Infinnium® & Matrix® Insegment binary restenosis at 9M IVUS% neointimal obstruction cost-effectiveness profile at 12M
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startMar 2006
- Primary completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary RestenosisStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CMS Medical
- Responsible party
- Sponsor
- Investigators
- Prof. Pedro A. Lemos, MD, Principal investigator, Instituto do Coração - InCor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752362
- Sponsor's protocol ID
- The PAINT Trial
- Status last verified
- Nov 2015
- First submitted
- 11 Sep 2008
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Martinez EE; PAINT study. Rationale and design for the PAINT randomized trial. Arq Bras Cardiol. 2009 Dec;93(6):547-53, 590-7. doi: 10.1590/s0066-782x2009001200006. English, Portuguese.
PubMed 20379631Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Martinez EE; PAINT trial investigators. Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):665-73. doi: 10.1002/ccd.22166.
PubMed 19670303Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE. Late clinical outcomes after implantation of drug-eluting stents coated with biodegradable polymers: 3-year follow-up of the PAINT randomised trial. EuroIntervention. 2012 May 15;8(1):117-9. doi: 10.4244/EIJV8I1A18.
PubMed 22580255Marchini JF, Gomes WF, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Lemos PA. Very late outcomes of drug-eluting stents coated with biodegradable polymers: insights from the 5-year follow-up of the randomized PAINT trial. Cardiovasc Diagn Ther. 2014 Dec;4(6):480-6. doi: 10.3978/j.issn.2223-3652.2014.12.05.
PubMed 25610805
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PercutAneous INTervention With Biodegradable- Polymer Based Paclitaxel-eluting, Sirolimus-eluting, or Bare Stents for the Treatment of de Novo Coronary Lesions.
- ClinicalTrials.gov ID
- NCT00752362
- Acronym / sponsor ID
- The PAINT Trial
- Conditions
- Coronary Restenosis
- Keywords
- Supralimus®,, Infinnium®,, Matrix®,, Restenosis, Percutaneous, Revascularization, Techniques, Metallic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Sahajanand Medical Technologies LimitedIndustry (pharma, biotech, devices)
- Collaborators
- CMS Medical
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- First posted
- 15 Sep 2008 (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.
Objectives:
PRIMARY OBJECTIVE:
To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
SECONDARY OBJECTIVES:
Safety:
To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the occurrence de Serious Adverse Events (SAEs) within 5 years among the paclitaxel, sirolimus and control study arms.
To compare the occurrence of in-stent thrombosis within 5 years among the paclitaxel, sirolimus and control study arms.
Efficacy:
To compare the rate of angiographic success among the study groups To compare the rate of procedural success among the study groups To compare the incidence of clinically driven target lesion revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the incidence of clinically driven target vessel revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms.
To compare the 1-year, 3-year and 5-year cost-effectiveness profile of the paclitaxel, sirolimus and control study arms.
To compare the 9-month in-stent late loss of paclitaxel-eluting stents to the in-stent late loss of sirolimus-eluting stents To compare the 9-month in-segment late loss among the study groups To compare the 9-month in-stent and in-segment binary restenosis rate among the study groups To compare the IVUS percent neointimal obstruction among the study groups
Study Design:
In the present RANDOMIZED study, the paclitaxel-eluting stent Infinnium® and the sirolimus-eluting stent Supralimus® will be compared to a metallic stent with the same structure (Milennium Matrix®) but without drug elution for the treatment of de novo lesions in native coronaries. The study will be a multicenter clinical trial and will include patients for the treatment with one of the three study stents. In total, 275 patients will be enrolled, randomly allocated for the Infinnium®, Supralimus®, or Milennium Matrix® stents in a 2:2:1 proportion. Patients will be followed-up for 12 months after the index procedure. All patients will undergo a follow-up angiography at 9 months. A subgroup of 55 patients will be evaluated at 9 months with IVUS examination.
Treatment:
Patients will be treated, according to the randomization groups, with Infinnium®, Supralimus®, or Milennium Matrix® stents of 19 mm, 23 mm, or 29 mm and nominal diameters of 2.5, 3.0, and 3.5 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Milennium Matrix® (Control)Percutaneous coronary intervention with bare metal stent |
| 2 | Experimental | Device: Infinnium®Percutaneous coronary intervention with paclitaxel-eluting stent |
| 3 | Experimental | Device: Supralimus®Percutaneous coronary intervention with sirolimus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years;
- Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia;
- De novo coronary lesion (non-restenosis);
- Target lesion located in a native artery;
- Target lesion located in a vessel with diameter between 2.5-3.5 mm (visual analysis);
Key exclusion criteria (29 listed)
- GENERAL EXCLUSION CRITERIA
- Q-wave myocardial infarction < 48 hours before the index procedure
- Recent myocardial infarction, with or without Q waves, with cardiac markers levels still above the normal upper limits
- Left ventricle ejection fraction ≤30%
- Renal dysfunction (serum creatinine > 2.0 mg/dl [>177 µmol/l])
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 |
|---|---|---|
| Milennium Matrix® (Control)Also: Milennium Matrix®Percutaneous coronary intervention with bare metal stent | Device | 1 |
| Infinnium®Percutaneous coronary intervention with paclitaxel-eluting stent | Device | 2 |
| Supralimus®Percutaneous coronary intervention with sirolimus-eluting stent | Device | 3 |
Primary outcome
compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
Time frame: 9 months
1 secondary outcome
MACE at 1,9&12M, SAE & ST until 12M. Rate of angiographic & procedural success, TLR & TVR at 1&9M Instent LL between Supralimus®, Infinnium® & Matrix® Insegment binary restenosis at 9M IVUS% neointimal obstruction cost-effectiveness profile at 12M
Time frame: 1 Year
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 20 Nov 2015.
- Results publication: PubMed 20379631Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Martinez EE; PAINT study. Rationale and design for the PAINT randomized trial. Arq Bras Cardiol. 2009 Dec;93(6):547-53, 590-7. doi: 10.1590/s0066-782x2009001200006. English, Portuguese.
- Results publication: PubMed 19670303Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Martinez EE; PAINT trial investigators. Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):665-73. doi: 10.1002/ccd.22166.
- Results publication: PubMed 22580255Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE. Late clinical outcomes after implantation of drug-eluting stents coated with biodegradable polymers: 3-year follow-up of the PAINT randomised trial. EuroIntervention. 2012 May 15;8(1):117-9. doi: 10.4244/EIJV8I1A18.
- Results publication: PubMed 25610805Marchini JF, Gomes WF, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Lemos PA. Very late outcomes of drug-eluting stents coated with biodegradable polymers: insights from the 5-year follow-up of the randomized PAINT trial. Cardiovasc Diagn Ther. 2014 Dec;4(6):480-6. doi: 10.3978/j.issn.2223-3652.2014.12.05.
Related trials for Coronary Restenosis
Recruiting
Virtue® SAB in the Treatment of Coronary ISR Trial
Coronary Artery Disease
Recruiting
Prevail Global Study
Coronary Artery Disease
Active, not recruiting
SELUTION SLR™ 014 In-stent Restenosis
Coronary Restenosis
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
RecruitingObservational study
Abbott Vascular Medical Device Registry
Acute Myocardial Infarction, Restenoses, Coronary
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.
Prof. Pedro A. Lemos, MD principal investigator
Instituto do Coração - InCor
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infinnium® and Supralimus® in people with Coronary Restenosis, run by Sahajanand Medical Technologies Limited at 11 sites in Brazil.
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 9 inclusion and 29 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. 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?
compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents. (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 NCT00752362, which also lists 4 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 20 Nov 2015.