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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 s

Detailed Summary:
Sponsor: Sahajanand Medical Technologies Pvt. Ltd.

Current 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 ]

Original Primary Outcome: Same as current

Current 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 ]

Original Secondary Outcome: Same as current

Information By: Sahajanand Medical Technologies Pvt. Ltd.

Dates:
Date Received: September 11, 2008
Date Started: March 2006
Date Completion:
Last Updated: November 19, 2015
Last Verified: November 2015