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

Coronary Restenosis Clinical Trial

Official title:

PercutAneous INTervention With Biodegradable- Polymer Based Paclitaxel-eluting, Sirolimus-eluting, or Bare Stents for the Treatment of de Novo Coronary Lesions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752362
• Other study ID #: The PAINT Trial
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2008
• Last updated: November 19, 2015
• Start date: March 2006

Study information

• Verified date: November 2015
• Source: Sahajanand Medical Technologies Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years;

2. Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia;

3. De novo coronary lesion (non-restenosis);

4. Target lesion located in a native artery;

5. Target lesion located in a vessel with diameter between 2.5-3.5 mm (visual analysis);

6. Target lesion amenable to treatment with a single stent of up to 29 mm in length;

7. Target lesion with a diameter stenosis > 50% (visual analysis);

8. Acceptable candidate for surgical revascularization;

9. Signed informed consent term.

Exclusion Criteria:

GENERAL EXCLUSION CRITERIA

1. Q-wave myocardial infarction < 48 hours before the index procedure

2. Recent myocardial infarction, with or without Q waves, with cardiac markers levels still above the normal upper limits

3. Left ventricle ejection fraction =30%

4. Renal dysfunction (serum creatinine > 2.0 mg/dl [>177 µmol/l])

5. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3

6. White cell count < 3.000 cells/mm3

7. Suspected or known liver disease (including subclinical hepatitis)

8. Heart transplant recipient

9. Know allergy to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin, or stainless steel

10. Life expectancy < 12 months

11. Any medical condition that, in the opinion of the investigator, may interfere with the ideal participation in study

12. 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.

13. Coronary angioplasty (with or without stent) < 6 months in any segment of the target vessel

14. Previous coronary angioplasty (with or without stent), at any time, in a coronary segment < 5 mm (proximal or distal) from the target lesion

15. 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

1. Restenotic target lesion

2. Need for treatment of more than one lesion in the target vessel;

3. Diameter of the target vessel < 2.5 mm or > 3.5 mm (visual analysis)

4. Long target lesion, not amenable to treatment with a single stent of up to 29 mm in length, according to the operator's discretion

5. Significant (> 50%) unprotected left main lesion

6. Angiographic thrombus

7. Target lesion located in bypass graft

8. Occluded target vessel (antegrade flow TIMI 0 or 1)

9. Target lesion in ostial location;

10. Target lesion in a bifurcation site with a side branch > 2.5 mm or that may require stent implantation;

11. Calcified target lesion with anticipated unsuccessful balloon pre-dilatation;

12. Severely tortuous target vessel.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• Milennium Matrix® (Control)
Percutaneous coronary intervention with bare metal stent
• Infinnium®
Percutaneous coronary intervention with paclitaxel-eluting stent
• Supralimus®
Percutaneous coronary intervention with sirolimus-eluting stent

Locations

Country	Name	City	State
Brazil	Hospital Biocor	Belo Horizonte	Minas Gerais
Brazil	Hospital Universitário Walter Cantídio	Fortaleza	Ceará
Brazil	Hospital Natal Center	Natal	Rio Grande do Norte
Brazil	Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande do Sul
Brazil	Rede D'Or de Hospitais	Rio de Janeiro
Brazil	Hospital Santa Marcelina	São Paulo
Brazil	Hospital São Camilo	São Paulo
Brazil	Hospital São Paulo - UNIFESP	São Paulo
Brazil	Instituto do Coração - InCor	São Paulo
Brazil	Hospital Meridional Intercath	Vitória	Espirito Santo
Brazil	Hospital Universitário Cassiano Antonio de Moraes	Vitória -	Espírito Santo

Sponsors (2)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Pvt. Ltd.	CMS Medical

Country where clinical trial is conducted

Brazil, 

References & 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, — View Citation

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 platfor — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes