---
title: "RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia"
nct_id: NCT01132456
overall_status: COMPLETED
phase: NA
sponsor: Medtronic Vascular
study_type: INTERVENTIONAL
primary_condition: Ischemic Heart Disease
countries: India
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01132456.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01132456"
ct_last_update_post_date: 2016-06-13
last_seen_at: "2026-05-12T07:08:38.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia

**Official Title:** RESOLUTE Asia: Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Patient Population With Long Lesion(s) and/or Dual Vessels in Asia

**NCT ID:** [NCT01132456](https://clinicaltrials.gov/study/NCT01132456)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 312
- **Lead Sponsor:** Medtronic Vascular
- **Conditions:** Ischemic Heart Disease, Coronary Stenosis, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- **Start Date:** 2010-06
- **Completion Date:** 2016-04
- **CT.gov Last Update:** 2016-06-13

## Brief Summary

The purpose of this study is to document the safety and overall clinical performance of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a patient population with long lesion(s) and/or dual vessels requiring stent implantation.

## Detailed Description

A total of 249 to 411 patients will be enrolled from Asia at approximately 25 centers where Endeavor Resolute stent is commercially available. There are two study cohorts:

1. 38 mm cohort: a minimum of 46 patients and maximum of 111 patients with at least one lesion amenable to treatment with a 38 mm length Endeavor Resolute stent. Patients may have one or two lesions, if the two lesions are located in separate target vessels.
2. Dual vessel cohort: a minimum of 203 patients and maximum of 300 patients with dual vessel treatment where each vessel has a lesion with length ≤ 27 mm and reference vessel diameters between 2.25 mm and 4.0 mm.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
* Informed consent
* Patient agrees to comply with specified follow-up evaluations at same investigational site
* Single target lesion or two target lesions located in separate coronary arteries
* De novo lesion(s) in native coronary artery(ies)
* Target lesion(s) ≤ 35 mm in length (or both lesion lengths ≤ 27 mm for two lesions in separate target vessels to be considered for the dual vessel cohort)
* Target vessel(s) have reference vessel diameter 2.25 mm to 4.0 mm, (or 3.0 to 4.0 mm for it to be treated with a 38 mm length stent)

Exclusion Criteria:

* Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; WBC count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
* Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB \> lab upper limit of normal)
* Previous PCI of target vessel(s) within 9 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
* History of stroke or TIA within prior 6 months
* Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
* Inability to comply with required trial antiplatelet regimen
* Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
* Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
* Unprotected left main coronary artery disease
```

## Arms

- **Different patient subset** (EXPERIMENTAL) — Patients with dual vessel treatment where each vessel has a lesion with length ≤ 27 mm and reference vessel diameters between 2.25 mm and 4.0 mm.
- **38 mm Cohort** (EXPERIMENTAL) — Patients with at least one lesion amenable to treatment with a 38 mm length Endeavor Resolute stent. Patients may have one or two lesions, if the two lesions are located in separate target vessels.

## Interventions

- **Drug eluting stent treatment** (DEVICE) — Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation

## Primary Outcomes

- **Target Lesion Failure (TLF) for 38mm cohort and Target Vessel Failure (TVF) for dual vessel cohort** _(time frame: 12 months)_ — TLF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods. TVF is defined as composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target vessel revascularization (TVR).

## Secondary Outcomes

- **Death** _(time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr)_
- **MI** _(time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr)_
- **Cardiac death and MI** _(time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr)_
- **MACE** _(time frame: 30d, 6m, 9m, 12m, 18m, 2yr, 3yr)_
- **TLF** _(time frame: For 38mm cohort it is 30d, 6m, 9m, 18m, 2yr and 3yr. For dual vessel cohort it is 30d, 6m, 9m, 12m, 18m, 2yr and 3yr)_

## Locations (1)

- The Heart Care Clinic, Ahmedabad, Gujarat, India

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the heart care clinic|ahmedabad|gujarat|india` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01132456.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01132456*  
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