Study

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor Amplitude Vascular Systems, Inc.
Registry number NCT07510438
Started 8 May 2026 Today 16 October 2026 Estimated completion 1 December 2026

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
St. Vincent's Hospital Sydney NSW Recruiting
Monash Health, Victorian Heart Hospital Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 15

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

* ≥ 18 years of age

* Subjects with native coronary artery disease

* Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months

* The target lesion must be a single de novo coronary lesion

* The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and \<100% or Stenosis ≥50% and \<70% with evidence of ischemia

* Lesion length must not exceed 44 mm

Key Exclusion Criteria:

* Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure.

* Subject has New York Heart Association (NYHA) class III or IV heart failure.

* Subject has renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis.

* Subject has a previous stent in the target vessel implanted within last six months.

* Unprotected LMCA diameter stenosis \>30%.

* Target lesion has a myocardial bridge.

* Target vessel is excessively tortuous, defined as the presence of 2 or more bends \>90 degrees or 3 or more bends \>75 degrees.

* Evidence of aneurysm in target vessel within 10 mm of the target lesion.

* Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA.

* Target lesion is a bifurcation with ostial diameter stenosis ≥30%.

* Any previous stent within 10 mm of the target lesion.

Dates on the record

Started 8 May 2026
Estimated completion 1 December 2026
Registry last updated 17 August 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 17 August 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.