Dexamethasone-Eluting Stent in Acute Coronary Syndrome to Prevent Restenosis

Vessel Restenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190099
• Other study ID #: FEMH-93005
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2005
• Last updated: November 17, 2005
• Start date: January 2003
• Est. completion date: December 2003

Study information

• Verified date: December 2004
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is the restenosis. Restenosis results from complex pathophysiological response of the vascular tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular recoil. However, by way of the mechanical support of metallic stent, recoil is no more the major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal hyperplasia.

The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the first 3 days after balloon injury, when the inflammatory reaction is most severe throughout the course. At that time, anti-inflammatory drug as steroid wuold be helpful to prevent the course of restenosis. Until the end of the third week, smooth muscle cells migrate and then proliferate in the second and the third stage, and the key effort to prevent restenosis right now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be effective both in animal and human experience. The last stage is re-epithelization, estrogen could promote the process and was considered to be effective in this stage.

Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be the patient group with coronary artery disease is a heterogenous one.

We believe if we applied corticosteroid over the patient with elevated inflammatory parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be obvious.

In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be readily absorbed and then gradually released locally even 4 weeks after deployment.

We expected a reduction of In-stent restenosis in ACS patient by the method with no or few systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular ultrasound assessment would be performed according to pur protocol.

Description:

The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is the restenosis. Restenosis results from complex pathopysiological response of the vascular tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular recoil. However, by way of the mechanical support of metallic stent, recoil is no more the major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal hyperplasia.

The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the first 3 days after balloon injury, when the inflammatory reaction is most severe throughout the course. At that time, anti-inflammatory drug as steroid would be helpful to prevent the course of restenosis. Until the end of the third week, smooth muscle cells migrate and then proliferate in the second and the third stage, and the key effort to prevent restenosis right now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be effective both in animal and human experience. The last stage is re-epithelization, estrogen could promote the process and was considered to be effective in this stage.

Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be the patient group with coronary artery disease is a heterogenous one.

We believe if we applied corticosteroid over the patient with elevated inflammatory parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be obvious.

In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be readily absorbed and then gradually released locally even 4 weeks after deployment.

We expected a reduction of In-stent restenosis in ACS patient by the method with no or few systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular ultrasound assessment would be performed according to pur protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ACS patient

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Vessel Restenosis

Intervention

Device:
• Dexamethasone-Eluting Stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital