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NCT01635881 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter

A Phase 3 study, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 3
Development phase
60
Enrollment target

NCT01635881: Completed Phase 3 study, sponsored by Boston Scientific Corporation.

NCT01635881 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01635881, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 3
Development phase
60 participants
Enrollment target

Study Summary

To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.

Primary Outcome

Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon. 3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure

Interventions

  • DEVICE Emerge™ 1.20 mm PTCA Dilatation Catheter

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2012-07
Est. Completion 2012-12
Phase Phase 3
Boston Scientific Corporation

280 total trials

What the finished NCT01635881 record still lists

NCT01635881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Emerge™ 1.20 mm PTCA Dilatation Catheter is the first listed.

NCT01635881 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01635881 about?

NCT01635881 is a clinical study titled "Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter". To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.

What is the current status of trial NCT01635881?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2012-07. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01635881?

The interventions under investigation include: Emerge™ 1.20 mm PTCA Dilatation Catheter (DEVICE).

Who is sponsoring clinical trial NCT01635881?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01635881's enrollment target sits among peer trials

60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01635881, the US trial registry maintained by the National Library of Medicine. NCT01635881 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.