Last reviewed · How we verify
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
NA trial testing rotational atherectomy in Coronary Artery Disease in 60 participants. Completed in 12 December 2023.
| Lead sponsor | Samin Sharma, M.D., F.A.C.C., M.S.C.A.I. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 13 May 2022 |
| Primary completion | 4 April 2023 |
| Estimated completion | 12 December 2023 |
| Sites | 2 locations across United States |
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
18 and older, any sex, with Coronary Artery Disease or Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 6.7 | ± 1.7 |
| Rotational Atherectomy + Plain Old Balloon | 6.9 | ± 1.8 |
In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 5.9 | ± 1.4 |
| Rotational Atherectomy + Plain Old Balloon | 6.4 | ± 1.9 |
Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 86.1 | ± 17.5 |
| Rotational Atherectomy + Plain Old Balloon | 78.6 | ± 14.7 |
Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 112.5 | ± 19.4 |
| Rotational Atherectomy + Plain Old Balloon | 104.2 | ± 13.5 |
Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound.
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 1 | |
| Rotational Atherectomy + Plain Old Balloon | 3 |
Number of Participants with Stent malapposition after Percutaneous Coronary Intervention assessed by intravascular ultrasound. Malapposition is indicated by blood visible behind stent struts. Stents may be completely or only partially malapposed depending on how much of the stent is in contact with the lumen wall.
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 5 | |
| Rotational Atherectomy + Plain Old Balloon | 9 |
Number of Participants with Dissection after Rotational atherectomy and cutting balloon angioplasty /non-compliant balloon angioplasty (CBA/NCBA) assessed by intravascular ultrasound. A dissection or tear in the vessel wall
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 27 | |
| Rotational Atherectomy + Plain Old Balloon | 30 |
Number of Participants with a Calcium fracture after Rotational atherectomy and Cutting/Plain old balloon assessed by intravascular ultrasound. A fracture within the calcified area.
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 14 | |
| Rotational Atherectomy + Plain Old Balloon | 7 |
Defined as the minimal luminal diameter in stent after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 1.0 | ± 0.4 |
| Rotational Atherectomy + Plain Old Balloon | 1.1 | ± 0.3 |
Defined as the minimal luminal diameter in segment after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 1.5 | ± 0.3 |
| Rotational Atherectomy + Plain Old Balloon | 1.6 | ± 0.4 |
Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 25.8 | ± 8.6 |
| Rotational Atherectomy + Plain Old Balloon | 28.4 | ± 6.8 |
Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography
| Group | Value | 95% CI |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | 13.8 | ± 6.5 |
| Rotational Atherectomy + Plain Old Balloon | 14.8 | ± 6.1 |
Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Rotational Atherectomy + C… | Rotational Atherectomy + P… |
|---|---|---|---|
| Myocardial Infarction (MI) | Cardiac disorders | — | — |
| Staged Percutaneous Coronary Intervention (PCI) | Cardiac disorders | — | — |
| Revascularisation | Cardiac disorders | — | — |
| Peri-procedural chest pain | Cardiac disorders | — | — |
| Kidney Stone | Renal and urinary disorders | — | — |
| Reaction | System | Rotational Atherectomy + C… | Rotational Atherectomy + P… |
|---|---|---|---|
| Post-PCI Troponin Leak | Injury, poisoning and procedural complications | — | — |
| Dissection C Post CBA/POBA | Injury, poisoning and procedural complications | — | — |
| Dissection B Post CBA/POBA | Injury, poisoning and procedural complications | — | — |
| Post-PCI Troponin Leak (Staged PCI) | Injury, poisoning and procedural complications | — | — |
| Slow-Flow Post ROTA | Injury, poisoning and procedural complications | — | — |
| Staged PCI | Cardiac disorders | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — |
| Myocardial Infarction (MI) | Cardiac disorders | — | — |
| Plaque Shift | Injury, poisoning and procedural complications | — | — |
| Bleeding | Respiratory, thoracic and mediastinal disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Chest Pain, Not Specified | Cardiac disorders | — | — |
| Chromaturia | Renal and urinary disorders | — | — |
| Congestion | Infections and infestations | — | — |
| Contusion | Skin and subcutaneous tissue disorders | — | — |
| Diaphoresis | Endocrine disorders | — | — |
| Dissection Post IVUS | Injury, poisoning and procedural complications | — | — |
| Dissection B Post ROTA | Injury, poisoning and procedural complications | — | — |
| Dissection B Post ROTA; Dissection B Post CBA/POBA | Injury, poisoning and procedural complications | — | — |
| Dissection C Post ROTA | Injury, poisoning and procedural complications | — | — |
| Dissection C Post Stent | Injury, poisoning and procedural complications | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Hypertension | Cardiac disorders | — | — |
| Hypokalemia | General disorders | — | — |
| Hypotension | Cardiac disorders | — | — |
| Joint Swelling | General disorders | — | — |
| Lymphadenopathy | Immune system disorders | — | — |
| No-Flow Post Procedure | Injury, poisoning and procedural complications | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Slow-Flow Post CBA/POBA | Injury, poisoning and procedural complications | — | — |
| Slow-Flow Post Stent | Injury, poisoning and procedural complications | — | — |
| Vascular Access Site Infection | Injury, poisoning and procedural complications | — | — |
Most-reported serious reactions: Myocardial Infarction (MI), Staged Percutaneous Coronary Intervention (PCI), Revascularisation, Peri-procedural chest pain, Kidney Stone.
Data from ClinicalTrials.gov NCT04865588 adverse events section.
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04865588.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing