---
title: OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery
nct_id: NCT04276389
overall_status: UNKNOWN
phase: NA
sponsor: Beijing Anzhen Hospital
study_type: INTERVENTIONAL
primary_condition: Coronary Artery Disease
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04276389.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04276389"
ct_last_update_post_date: 2020-02-19
last_seen_at: "2026-05-12T06:03:11.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery

**Official Title:** OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery After Lesion Preparation With Scoring Balloon - A Prospective Multicenter Cohort Study

**NCT ID:** [NCT04276389](https://clinicaltrials.gov/study/NCT04276389)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Beijing Anzhen Hospital
- **Conditions:** Coronary Artery Disease
- **Start Date:** 2017-08-01
- **Completion Date:** 2020-08-31
- **CT.gov Last Update:** 2020-02-19

## Brief Summary

OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. 18 to 85 years old
2. Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, or silent ischemia.
3. Reference vessel diameter \>2.5 mm, and \<4.0 mm.
4. Lesion length of \<22 mm
5. Written informed consent

Exclusion Criteria:

1. Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
2. Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA or Killip≥3)
3. Chronic kidney disease (eGFR \<30 ml/min)
4. Lesion length \>22 mm, or vessel diameters of \<2.5 mm or \>4.0 mm
5. Stents covering a major side branch (\>2 mm)
6. Left main lesion
7. Graft lesion
8. Aortic-coronary ostial lesion
9. In-stent restenotic lesion
10. Chronic total occlusion
11. Severe calcified lesions.
12. Visible angiographic thrombus
13. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
```

## Arms

- **OCT-guided arm** (ACTIVE_COMPARATOR)
- **Angiography-guided arm** (PLACEBO_COMPARATOR)

## Interventions

- **OCT-guided paclitaxel drug-coated balloon angioplasty** (DEVICE) — OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
- **Angiography-guided paclitaxel drug-coated balloon angioplasty** (DEVICE) — Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery

## Primary Outcomes

- **Late lumen loss** _(time frame: 9 months)_ — Evaluated by QCA

## Secondary Outcomes

- **Rate of binary restenosis** _(time frame: 9 months)_
- **Target lesion failure** _(time frame: 9 months)_

## Locations (1)

- Beijing Anzhen Hospital, Capital Medical University, Beijing, China — _RECRUITING_

## 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.maxAge` — 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.beijing anzhen hospital, capital medical university|beijing||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04276389.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04276389*  
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