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NCT07000045 · ClinicalTrials.gov registry record · NA
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
A NA study of Coronary Artery Disease and Coronary Calcification, sponsored by Annapoorna Kini.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07000045: Recruiting NA study of Coronary Artery Disease and Coronary Calcification, sponsored by Annapoorna Kini.
NCT07000045 is a NA study of Coronary Artery Disease and Coronary Calcification that is actively recruiting participants, run by Annapoorna Kini. The registered enrollment target is 120 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07000045, a NA study of Coronary Artery Disease and Coronary Calcification, is actively recruiting participants, sponsored by Annapoorna Kini.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (Cohort B).
Primary Outcome
Post-procedural minimum stent area measured at the site of the calcified nodule (Cohort A) or the point of maximum calcification (Cohort B), as assessed by optical coherence tomography (OCT)
Conditions Studied
Interventions
- DEVICE Intravascular lithotripsy
- DEVICE Rotational atherectomy
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-10-06 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT07000045 shows while recruiting
NCT07000045 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Intravascular lithotripsy is the first listed.
NCT07000045 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07000045 about?
NCT07000045 is a clinical study titled "Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment". The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined ...
What is the current status of trial NCT07000045?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-10-06. Estimated completion is 2027-12-31.
What conditions does trial NCT07000045 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Coronary Calcification.
What interventions are being tested in trial NCT07000045?
The interventions under investigation include: Intravascular lithotripsy (DEVICE), Rotational atherectomy (DEVICE).
Who is sponsoring clinical trial NCT07000045?
This trial is sponsored by Annapoorna Kini, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07000045 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07000045's enrollment target sits among peer trials
120 137th of 219 higher than 81 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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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