Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

Part of paid clinical trials in New York, New York.

Sponsor
Annapoorna Kini
Study ID
NCT07000045
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease
  • Coronary Calcification

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravascular lithotripsy — DEVICE
    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 atherectomy — DEVICE
    Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.

Study Details

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).

Key Dates

Start date
Oct 6, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RA + IVL (Cohort A)
    Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting.
  • Active Comparator: IVL alone (Cohort A)
    Patients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting.
  • Experimental: Maximum IVL pulses (Cohort B)
    Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using the maximum number of pulses per manufacturer's instructions.
  • Active Comparator: Operator-determined IVL pulses (Cohort B)
    Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using a pulse number determined at the operator's discretion.

Primary Outcome Measure

Minimum stent area (MSA) [ Time Frame: Immediately after Index procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Annapoorna S Kini, MD
[email protected]
(212) 241-4181
Keisuke Yasumura, MD
[email protected]
212-241-4181
Annapoorna S Kini (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Mount Sinai Hospital· New York, NY

Related Studies