Coronary Artery DiseaseNODULE-SHOCKNCT07000045
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
A study testing Intravascular lithotripsy and Rotational atherectomy in people with Coronary Artery Disease and Coronary Calcification, run by Annapoorna Kini at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Calcification
- What is being tested?
- Intravascular lithotripsy and Rotational atherectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 11 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years who signed written informed consent
- Presence of a clinical indication for coronary intervention
- Patients undergoing PCI for a de novo calcified lesion with planned drug-eluting stent (DES) implantation
- Native coronary artery with significant stenosis defined as:
- ≥70% and <100% stenosis on angiography, or
- 50-70% stenosis with evidence of ischemia (positive stress test, FFR ≤ 0.8, or OCT minimal lumen area (MLA) ≤ 4.0 mm2)
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- Reference vessel diameter: ≥2.5 mm to ≤ 4.0 mm
- Lesion length: ≥5mm
- Moderate to severe calcification of the target lesion confirmed by angiography
- Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline
Who cannot join
- Cardiogenic shock at the time of procedure
- Primary PCI for ST-segment elevation myocardial infarction (STEMI)
- Pregnant, nursing, or childbearing potential without adequate contraception
- Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)
- Planned surgery within 6 months unless DAPT can be maintained
- Life expectancy <12 months due to a serious medical illness (e.g., advanced cancer, end-stage heart failure)
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- Severe kidney dysfunction (CrCl <30 mL/min) without dialysis
- Concurrent participation in another investigational study
- Referral for coronary artery bypass grafting (CABG) after a heart team discussion
- Angiographic evidence of thrombus at the target lesion
- Angiographic evidence of significant dissection at the treatment site prior to intervention
- Lesion with a previously placed stent within 10mm (visual estimate)
- Last remaining vessel with severely compromised left ventricular function (LVEF <30%)
- Target lesion within a saphenous vein graft (SVG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
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).
Read the detailed description
The trial consists of two cohorts:
- Patients with calcified nodules (CN) (Cohort A)
- Patients with non-nodular severe coronary calcium (Cohort B)
Randomization will occur as follows:
- Rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone for lesion preparation prior to stenting (Cohort A).
- Operator-determined or maximum IVL pulses prior to stenting. (Cohort B)
The trial is designed to compare two calcium modification strategies in each cohort with regard to the primary endpoints of post-procedural minimum stent area assessed by optical coherence tomography at the CN site (Cohort A) and at the site of maximum calcification (Cohort B).
- Conditions
- Coronary Artery Disease, Coronary Calcification
- Being tested
- Intravascular lithotripsy, Rotational atherectomy
- Keywords
- Coronary calcification, Calcified nodule, Intravascular lithotripsy, Rotational atherectomy, Optical coherence tomography, Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular lithotripsyDevice
Intravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting.
Rotational atherectomyDevice
Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.
| Study group | Role | What they receive |
|---|---|---|
| RA + IVL (Cohort A) | Experimental | Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting. Receives: Device: Intravascular lithotripsy; Device: Rotational atherectomy |
| IVL alone (Cohort A) | Active comparator | Patients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting. Receives: Device: Intravascular lithotripsy |
| Maximum IVL pulses (Cohort B) | Experimental | Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using the maximum number of pulses per manufacturer's instructions. Receives: Device: Intravascular lithotripsy |
| Operator-determined IVL pulses (Cohort B) | Active comparator | Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using a pulse number determined at the operator's discretion. Receives: Device: Intravascular lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum stent area (MSA)
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)
Measured: Immediately after Index procedure
Secondary outcomes (11)
Number of Calcium fractures
Number and presence of post-IVL calcium fractures identified on OCT
Measured: Immediately after Index procedure
Target vessel failure (TVF)
Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization
Measured: during hospitalization, approximately 1-2 days, 30 days, and 12 months
Stent thrombosis
Definite or probable stent thrombosis according to academic research consortium-2 (ARC-2) definitions.
Definite stent thrombosis is defined as the presence of a thrombus within the stent, within 5 mm of the stent edge, or in a side branch of the stented segment, confirmed by angiography or pathology, along with evidence of acute ischemia such as symptoms, ECG changes, or elevated cardiac biomarkers.
Probable is defined as a myocardial infarction in the territory of the stented vessel without angiographic confirmation and without another obvious cause.
Measured: 12 months
Device success
Successful lesion crossing and device delivery to the target site
Measured: Immediately after Index procedure
Angiographic success
Angiographic success defined as stent deployment with residual stenosis <30% and TIMI 3 flow without significant angiographic complications (perforation, major dissection, distal embolization, slow flow, or no flow)
Measured: Immediately after Index procedure
Procedural success
Procedural success defined as angiographic success and no in-hospital TVF
Measured: Immediately after Index procedure
Bailout or adjunctive calcium modification
Use of additional calcium modification device beyond initial randomized strategy
Measured: Intraoperatively during Index procedure
Pre- and post-dilatation ballon size
Balloon size recorded during lesion preparation and post-dilatation
Measured: Immediately before and after Index procedure
Pre- and post-dilatation inflation pressure
Inflation pressure recorded during lesion preparation and post-dilatation
Measured: Immediately before and after Index procedure
Total number of IVL pulses delivered to the lesion during treatment
IVL pulse characteristics - Total number of IVL pulses delivered to the lesion during treatment relative to overall lesion length and calcified segment length
Measured: Intraoperatively during Index procedure
Lesion length of IVL pulses delivered
IVL pulse characteristics - The lesion length over which pulses were applied, relative to overall lesion length and calcified segment length
Measured: Intraoperatively during Index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start6 Oct 2025
- Primary completion11 Aug 2026
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort A: RA + IVL vs IVL alone for calcified nodules Cohort B: Operator-determined IVL pulses vs Maximum IVL pulses for non-CN severe calcium
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annapoorna Kini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Annapoorna Kini, Icahn School of Medicine at Mount Sinai
- Investigators
- Annapoorna S Kini, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000045
- Sponsor's protocol ID
- STUDY-25-00266
- Other IDs
- ISR20250319
- Acronym
- NODULE-SHOCK
- Status last verified
- Oct 2026
- First submitted
- 23 May 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data will only be shared with the study funder for internal use. No public IPD sharing is planned.
Publications
Kini AS, Yasumura K, Nakao S, Oliva A, Revaiah PC, Vengrenyuk Y, Hooda A, Ranadive I, Penta B, Baruah N, Khera S, Sweeny J, Sharma R, Kapur V, Krishnan P, Moreno P, Dangas G, Mehran R, Sharma SK. Rotational Atherectomy Plus Intravascular Lithotripsy Versus Intravascular Lithotripsy Alone for Coronary Calcified Nodules: The NODULE-SHOCK Trial. JACC Cardiovasc Interv. 2026 Nov 1:S1936-8798(26)02693-2. doi: 10.1016/j.jcin.2026.10.001. Online ahead of print.
PubMed 42969902
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
- ClinicalTrials.gov ID
- NCT07000045
- Acronym / sponsor ID
- NODULE-SHOCK / STUDY-25-00266
- Conditions
- Coronary Artery Disease, Coronary Calcification
- Keywords
- Coronary calcification, Calcified nodule, Intravascular lithotripsy, Rotational atherectomy, Optical coherence tomography, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Annapoorna KiniUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 11 Aug 2026 (actual)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The trial consists of two cohorts:
- Patients with calcified nodules (CN) (Cohort A)
- Patients with non-nodular severe coronary calcium (Cohort B)
Randomization will occur as follows:
- Rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone for lesion preparation prior to stenting (Cohort A).
- Operator-determined or maximum IVL pulses prior to stenting. (Cohort B)
The trial is designed to compare two calcium modification strategies in each cohort with regard to the primary endpoints of post-procedural minimum stent area assessed by optical coherence tomography at the CN site (Cohort A) and at the site of maximum calcification (Cohort B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Cohort A: RA + IVL vs IVL alone for calcified nodules Cohort B: Operator-determined IVL pulses vs Maximum IVL pulses for non-CN severe calcium
| Arm | Type | Receives |
|---|---|---|
| RA + IVL (Cohort A) | Experimental | Device: Intravascular lithotripsy, Device: Rotational atherectomyPatients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting. |
| IVL alone (Cohort A) | Active comparator | Device: Intravascular lithotripsyPatients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting. |
| Maximum IVL pulses (Cohort B) | Experimental | Device: Intravascular lithotripsyPatients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using the maximum number of pulses per manufacturer's instructions. |
| Operator-determined IVL pulses (Cohort B) | Active comparator | Device: Intravascular lithotripsyPatients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using a pulse number determined at the operator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years who signed written informed consent
- Presence of a clinical indication for coronary intervention
- Patients undergoing PCI for a de novo calcified lesion with planned drug-eluting stent (DES) implantation
- Native coronary artery with significant stenosis defined as:
- ≥70% and <100% stenosis on angiography, or
Key exclusion criteria (14 listed)
- Cardiogenic shock at the time of procedure
- Primary PCI for ST-segment elevation myocardial infarction (STEMI)
- Pregnant, nursing, or childbearing potential without adequate contraception
- Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)
- Planned surgery within 6 months unless DAPT can be maintained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular lithotripsyIntravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting. | Device | IVL alone (Cohort A), Maximum IVL pulses (Cohort B), Operator-determined IVL pulses (Cohort B), RA + IVL (Cohort A) |
| Rotational atherectomyRotational atherectomy device used to debulk calcified nodules before IVL and stent implantation. | Device | RA + IVL (Cohort A) |
Primary outcome
Minimum stent area (MSA)
Time frame: Immediately after Index procedure
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)
11 secondary outcomes
Number of Calcium fractures
Time frame: Immediately after Index procedure
Target vessel failure (TVF)
Time frame: during hospitalization, approximately 1-2 days, 30 days, and 12 months
Stent thrombosis
Time frame: 12 months
Device success
Time frame: Immediately after Index procedure
Angiographic success
Time frame: Immediately after Index procedure
Procedural success
Time frame: Immediately after Index procedure
Bailout or adjunctive calcium modification
Time frame: Intraoperatively during Index procedure
Pre- and post-dilatation ballon size
Time frame: Immediately before and after Index procedure
Pre- and post-dilatation inflation pressure
Time frame: Immediately before and after Index procedure
Total number of IVL pulses delivered to the lesion during treatment
Time frame: Intraoperatively during Index procedure
Lesion length of IVL pulses delivered
Time frame: Intraoperatively during Index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 42969902Kini AS, Yasumura K, Nakao S, Oliva A, Revaiah PC, Vengrenyuk Y, Hooda A, Ranadive I, Penta B, Baruah N, Khera S, Sweeny J, Sharma R, Kapur V, Krishnan P, Moreno P, Dangas G, Mehran R, Sharma SK. Rotational Atherectomy Plus Intravascular Lithotripsy Versus Intravascular Lithotripsy Alone for Coronary Calcified Nodules: The NODULE-SHOCK Trial. JACC Cardiovasc Interv. 2026 Nov 1:S1936-8798(26)02693-2. doi: 10.1016/j.jcin.2026.10.001. Online ahead of print.
- Individual participant dataSharing planned: No. De-identified data will only be shared with the study funder for internal use. No public IPD sharing is planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annapoorna S Kini, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular lithotripsy and Rotational atherectomy in people with Coronary Artery Disease and Coronary Calcification, run by Annapoorna Kini at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum stent area (MSA) (time frame: Immediately after Index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.