Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)

NCT00752362 | Completed Phase 4 DMC

• 1 other identifier: The PAINT Trial
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 11

Brief 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 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

Keywords

Supralimus®,; Infinnium®,; Matrix®,; Restenosis; Percutaneous; Revascularization; Techniques; Metallic; Platform; Agents; Antiproliferative; Properties

Outcome Measures

Primary Outcomes (1)

• compare the in-stent late loss at 9M of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.

  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

  1 Year

Study Arms (3)

1

ACTIVE COMPARATOR

Percutaneous coronary intervention with bare metal stent

Device: Milennium Matrix® (Control)

2

EXPERIMENTAL

Percutaneous coronary intervention with paclitaxel-eluting stent

Device: Infinnium®

3

EXPERIMENTAL

Percutaneous coronary intervention with sirolimus-eluting stent

Device: Supralimus®

Interventions

Milennium Matrix® (Control) DEVICE

Percutaneous coronary intervention with bare metal stent

Also known as: Milennium Matrix®

1

Infinnium® DEVICE

Percutaneous coronary intervention with paclitaxel-eluting stent

2

Supralimus® DEVICE

Percutaneous coronary intervention with sirolimus-eluting stent

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Target lesion with a diameter stenosis \> 50% (visual analysis);
• Acceptable candidate for surgical revascularization;
• Signed informed consent term.

You may not qualify if:

• 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
• 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
• 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.
• Restenotic target lesion

Sponsors & Collaborators

• Sahajanand Medical Technologies Limited: lead
• CMS Medical: collaborator

Study Sites (11)

Hospital Universitário Walter Cantídio

Fortaleza, Ceará, 60430-370, Brazil

Location

Hospital Universitário Cassiano Antonio de Moraes

Vitória, Espírito Santo, 29042-755, Brazil

Location

Hospital Meridional Intercath

Vitória, Espírito Santo, 29156-580, Brazil

Location

Hospital Biocor

Belo Horizonte, Minas Gerais, 34000-000, Brazil

Location

Rede D'Or de Hospitais

Rio de Janeiro, Rio de Janeiro, 20941-150, Brazil

Location

Hospital Natal Center

Natal, Rio Grande do Norte, 59054-630, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital São Paulo - UNIFESP

São Paulo, São Paulo, 04024-002, Brazil

Location

Hospital São Camilo

São Paulo, São Paulo, 05022-001, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-070, Brazil

Location

Instituto do Coração - InCor

São Paulo, 05403-900, Brazil

Location

Related Publications (4)

• 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.

  PMID: 20379631 RESULT

• 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 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.

  PMID: 19670303 RESULT

• 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. 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.

  PMID: 22580255 RESULT

• Marchini 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.

  PMID: 25610805 RESULT

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Prof. Pedro A. Lemos, MD

  Instituto do Coração - InCor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

BR (11)