---
title: Alwide Plus China Post-market Clinical Investigation
nct_id: NCT07304427
overall_status: COMPLETED
sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
study_type: OBSERVATIONAL
primary_condition: Severe Aortic Stenosis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07304427.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07304427"
ct_last_update_post_date: 2025-12-26
last_seen_at: "2026-05-12T07:02:54.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Alwide Plus China Post-market Clinical Investigation

**Official Title:** A Prospective, Multicenter, Post-market Clinical Investigation to Evaluate the Pre-dilation Safety and Effectiveness of Alwide Plus Balloon Catheter of MicroPort CardioFlow in Transcatheter Aortic Valve Replacement

**NCT ID:** [NCT07304427](https://clinicaltrials.gov/study/NCT07304427)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 75
- **Lead Sponsor:** Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- **Conditions:** Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
- **Start Date:** 2025-01-03
- **Completion Date:** 2025-11-04
- **CT.gov Last Update:** 2025-12-26

## Brief Summary

This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.

## Detailed Description

The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.

## Eligibility

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

```
Inclusion Criteria:

* Age≥18 years old;
* Severe aortic stenosis verified by echocardiogram: mean transvalvular gradient≥40mmHg (1mmHg=0.133kPa), or peak aortic jet velocity≥4m/s, or aortic valve area (AVA) ≤ 1.0cm2 (or AVA index≤ 0.6cm2/m2);
* Patients, who can understand the clinical investigation purpose, voluntary agree and sign the informed consent form, and willing to comply with relevant trial assessments and clinical follow up

Exclusion Criteria:

* Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure
* TAVR procedure in trans-apical access
* Pre-implanted mechanical or bioprosthetic valve at the aortic valve position
* Acute myocardial infarction (MI) occurred in the last 30 days before the treatment；
* LVOT obstruction;
* Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%
* Echocardiographic evidence of intracardiac mass, thrombus or neoplasm；
* Unable to receive anticoagulation or antiplatelet therapy；
* Allergy to nitinol or sensitive contrast media；
* Active bacterial endocarditis or other active infection may affect the procedure；
* Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator team；
* Life expectancy \> 12 months；
* vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease；
* Patients who participated in other clinic trials of drugs or medical device before being enrolled for which the primary endpoint follow up duration has not been reached；
* Investigators determined that patients have poor compliance and can't complete the study as required
```

## Arms

- **Alwide Plus** — Paitents perfomed TAVR and have Alwlide Plus Balloon Catheter pre-dilaton or post-dilation

## Primary Outcomes

- **Percentage of patients with TAVI device success at immediate post-procedure** _(time frame: Immediate post-procedure)_ — TAVI device success, defined as (meeting all the following criteria):

Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient \<20mmHg, or peak velocity \<3 m/s, and no severe aortic regurgitation or paravalvular leakage).

## Secondary Outcomes

- **Percentage of patients with balloon pre-dilation success** _(time frame: Immediate post-procedure)_
- **Percentage of paitents with balloon post-dilation success** _(time frame: Immediate post-procedure)_
- **Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKIN≥2), major vascular complications and new permanent pacemaker implantation** _(time frame: Immediate post-procedure and 30 days post-procedure)_
- **Prosthetic valve performance-mean transvalular pressure gradient** _(time frame: Immediate post-procedure and discharge(within 7 days post-procedure))_
- **Prosthetic valve performance-orifice area** _(time frame: Immediate post-procedure and discharge(within 7 days post-procedure))_
- **Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage)** _(time frame: Immediate post-procedure and discharge(within 7 days post-procedure))_

## Locations (4)

- Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China
- Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China
- Yan'an Hospital of Kunming City, Kunming, Yunnan, China
- Guangdong Provincial People's Hospital, Guangzhou, China

## 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.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)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.affiliated hospital of guangdong medical university|zhanjiang|guangdong|china` — added _(2026-05-12)_
- `locations.jiangxi provincial people's hospital|nanchang|jiangxi|china` — added _(2026-05-12)_
- `locations.yan'an hospital of kunming city|kunming|yunnan|china` — added _(2026-05-12)_
- `locations.guangdong provincial people's hospital|guangzhou||china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07304427*  
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