Trial Outcomes & Findings for Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions (NCT NCT04865588)

Results Overview

Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Post-procedure, Day 0

Results posted on

2024-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Rotational Atherectomy + Cutting Balloon angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Overall Study STARTED	29	31
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement	Total n=60 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 10.0 • n=5 Participants	72.8 years STANDARD_DEVIATION 8.7 • n=7 Participants	71.1 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	20 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Hypertension	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Hyperlipidaemia	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Diabetes mellitus	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Insulin	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Current smoker	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Family history of coronary artery disease (CAD)	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Peripheral arterial disease	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Cerebrovascular disease	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Chronic renal insufficiency	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Left ventricular ejection fraction (LVEF)	55.6 percent STANDARD_DEVIATION 9.8 • n=5 Participants	57.3 percent STANDARD_DEVIATION 7.6 • n=7 Participants	56.5 percent STANDARD_DEVIATION 8.7 • n=5 Participants
Prior coronary artery bypass grafting (CABG)	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Prior percutaneous coronary intervention (PCI)	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Prior myocardial infarction (MI)	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Prior stroke	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-procedure, Day 0

Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Minimum Stent Area After Percutaneous Coronary Intervention	6.7 mm^2 Standard Deviation 1.7	6.9 mm^2 Standard Deviation 1.8

SECONDARY outcome

Timeframe: Post-procedure, Day 0

In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation	5.9 mm^2 Standard Deviation 1.4	6.4 mm^2 Standard Deviation 1.9

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Minimum Percent Stent Expansion After Percutaneous Coronary Intervention	86.1 minimum percent expansion Standard Deviation 17.5	78.6 minimum percent expansion Standard Deviation 14.7

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Mean Percent Stent Expansion After Percutaneous Coronary Intervention	112.5 mean percent expansion Standard Deviation 19.4	104.2 mean percent expansion Standard Deviation 13.5

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound.

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Dissection After Percutaneous Coronary Intervention	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Post-Procedure, Day 0

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.

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention	5 Participants	9 Participants

SECONDARY outcome

Timeframe: Post-CBA/NCBA before stent, Day 0

Population: one participant missing imaging for this outcome measure

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

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=28 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)	27 Participants	30 Participants

SECONDARY outcome

Timeframe: Post-Procedure, Day 0

Population: one participant missing imaging for this outcome measure

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.

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=28 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon	14 Participants	7 Participants

SECONDARY outcome

Timeframe: Post-procedure, Day 0

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).

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography	1.0 mm Standard Deviation 0.4	1.1 mm Standard Deviation 0.3

SECONDARY outcome

Timeframe: Post-procedure, Day 0

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).

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography	1.5 mm Standard Deviation 0.3	1.6 mm Standard Deviation 0.4

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Percent Residual Diameter Stenosis In-segment After Stent Implantation	25.8 percent residual diameter stenosis Standard Deviation 8.6	28.4 percent residual diameter stenosis Standard Deviation 6.8

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Percent Residual Diameter Stenosis In-stent After Stent Implantation	13.8 percent residual diameter stenosis Standard Deviation 6.5	14.8 percent residual diameter stenosis Standard Deviation 6.1

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Minimum lumen diameter in-segment after stent implantation assessed by Angiography

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Minimum Lumen Diameter In-segment After Stent Implantation	2.1 mm Standard Deviation 0.3	2.1 mm Standard Deviation 0.4

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Minimum lumen diameter in-stent after stent implantation assessed by Angiography

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Minimum Lumen Diameter In-stent After Stent Implantation	2.5 mm Standard Deviation 0.3	2.5 mm Standard Deviation 0.4

SECONDARY outcome

Timeframe: Post-CBA/NCBA before stent and after stent, Day 0

Population: three participants missing imaging for this outcome measure

Number of Participants with Dissection Type B or greater before and after stent implantation assessed by Angiography.

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=28 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=29 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Dissection Type B or Greater Post-CBA/NCBA before stent	6 Participants	13 Participants
Number of Participants With Dissection Type B or Greater Post-CBA/NCBA after stent	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography. Perforation of a vessel

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-procedure, Day 0

Number of Participants with side branch closure after stent implantation assessed by Angiography. Occlusion of a side branch

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Side Branch Closure After Stent Implantation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-Procedure, Day 0

Device problem; Rupture of the cutting balloon or plain old balloon

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With a Balloon Rupture	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-Procedure, Day 0

Device problem; detachment of a blade from the cutting balloon

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Blade Detachment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Post-Procedure, Day 0

Device problem; difficulty in moving the balloon within the vessel during the procedure

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Difficulty in Withdrawing/Advancing the Device	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Cardiac Death

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Non-Cardiac Death

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

The Society for Cardiovascular Angiography and Intervention (SCAI) defines clinically relevant MI after PCI as an elevation of cardiac biomarkers (CK-MB or troponin) above specified thresholds within 48 hours of the procedure, with or without new Q waves or LBBB on ECG. This definition aims to identify meaningful ischemic injury to the myocardium that is associated with adverse clinical outcomes.

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Myocardial infarction is defined as heart muscle damage due to lack of blood flow, based on characteristic symptoms, ECG changes, and cardiac biomarker elevation, especially troponin. Elevated levels of cardiac biomarkers, especially troponin, along with ECG changes and cardiac symptoms, indicate myocardial infarction according to the universal definition.

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention	26.9 percent of participants	13.2 percent of participants

SECONDARY outcome

Timeframe: 30 days

Revascularization

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Revascularization

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Stent Thrombosis

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Bleeding Academic Research Consortium (BARC) Type 3 1. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding 2. Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 5 1. Probable fatal bleeding 2. Definite fatal bleeding (overt or autopsy or imaging confirmation)

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Vascular complication

Outcome measures

Outcome measures
Measure	Rotational Atherectomy + Cutting Balloon n=29 Participants angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 Participants angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Number of Participants With Vascular Complications After Percutaneous Coronary Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 270 days

The Canadian Cardiovascular Society (CCS) grading scale is a classification system used to grade the severity of angina pectoris based on symptoms and their relationship to physical activity. Grade I: Ordinary physical activity like walking does not cause angina. Angina only occurs with strenuous, rapid, prolonged exertion during recreation or work. Grade II: Slight limitation of ordinary activity. Angina occurs when walking/climbing stairs rapidly, walking uphill, after meals, in cold/wind, under stress, or early morning. Angina occurs when walking more than 2 blocks or climbing more than 1 flight of stairs at a normal pace. Grade III: Marked limitation of ordinary activity. Angina occurs when walking 1-2 blocks or climbing 1 flight of stairs at a normal pace. Grade IV: Inability to carry out any physical activity without angina. Anginal symptoms may be present at rest. Higher grades indicate more limitations to activity due to angina.

Outcome measures

Outcome data not reported

Adverse Events

Rotational Atherectomy + Cutting Balloon

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Rotational Atherectomy + Plain Old Balloon

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rotational Atherectomy + Cutting Balloon n=29 participants at risk angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 participants at risk angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Cardiac disorders Myocardial Infarction (MI)	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	6.5% 2/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Revascularisation	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Peri-procedural chest pain	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Staged Percutaneous Coronary Intervention (PCI)	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	6.5% 2/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Renal and urinary disorders Kidney Stone	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.

Other adverse events

Additional Information

Director of The Zena and Michael A. Wiener Cardiovascular Institute

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-4021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Since study is being conducted at two sites, PIs agree that study results must be published in an integrated manner reflecting results from both sites. Written consent from ISMMS is required for publication. If there is no multi-site publication within 18 months after the study has been completed or terminated at all Study locations, Pl shall have the right to publish and/or present the results of the study generated at their site.
Publication restrictions are in place

Restriction type: OTHER

Measure	Rotational Atherectomy + Cutting Balloon n=29 participants at risk angioplasty with rotational atherectomy followed by cutting balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification 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	Rotational Atherectomy + Plain Old Balloon n=31 participants at risk angioplasty with rotational atherectomy followed by plain old balloon rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification plain old balloon: current standard treatment of stent placement
Cardiac disorders Atrial Fibrillation	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	6.5% 2/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Respiratory, thoracic and mediastinal disorders Bleeding	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Renal and urinary disorders Hematuria	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Bradycardia	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Chest Pain, Not Specified	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Renal and urinary disorders Chromaturia	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Infections and infestations Congestion	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Skin and subcutaneous tissue disorders Contusion	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Endocrine disorders Diaphoresis	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Dissection Post IVUS	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Dissection B Post CBA/POBA	10.3% 3/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Dissection B Post ROTA	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Dissection B Post ROTA; Dissection B Post CBA/POBA	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Dissection C Post CBA/POBA	10.3% 3/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	22.6% 7/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Dissection C Post ROTA	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Dissection C Post Stent	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
General disorders Fatigue	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Hypertension	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
General disorders Hypokalemia	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Hypotension	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
General disorders Joint Swelling	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Immune system disorders Lymphadenopathy	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Myocardial Infarction (MI)	6.9% 2/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	6.5% 2/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications No-Flow Post Procedure	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Plaque Shift	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	6.5% 2/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Post-PCI Troponin Leak	55.2% 16/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	64.5% 20/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Post-PCI Troponin Leak (Staged PCI)	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	9.7% 3/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Skin and subcutaneous tissue disorders Rash	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Slow-Flow Post CBA/POBA	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Slow-Flow Post ROTA	10.3% 3/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	6.5% 2/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Slow-Flow Post Stent	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	0.00% 0/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Cardiac disorders Staged PCI	3.4% 1/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	9.7% 3/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.
Injury, poisoning and procedural complications Vascular Access Site Infection	0.00% 0/29 • 30 days All 30 day primary outcome site-reported adverse events were collected.	3.2% 1/31 • 30 days All 30 day primary outcome site-reported adverse events were collected.