Trial Outcomes & Findings for CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings (NCT NCT00595959)

NCT ID: NCT00595959

Last Updated: 2011-07-12

Results Overview

The primary efficacy endpoint is laser success, defined as achieving \>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 65 participants
• Primary outcome timeframe: Measured at time of procedure
• Results posted on: 2011-07-12

Participant Flow

Patients were recruited from investigator patient referral base. Recruitment occurred between November 2006 and March 2007

Patients were screened for inclusion/exclusion criteria

Participant milestones

Measure	Laser Treatment CLiRpath Photoablation Atherectomy System
Overall Study STARTED	65
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Laser Treatment CLiRpath Photoablation Atherectomy System
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Baseline characteristics by cohort

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Age Continuous	68.3 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants
Race/Ethnicity Hispanic or Latino	5 participants n=5 Participants
Race/Ethnicity Not Hispanic or Latino	49 participants n=5 Participants
Race/Ethnicity African American	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at time of procedure

Population: Per protocol

The primary efficacy endpoint is laser success, defined as achieving >/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Laser Success	34.7 percent reduction Standard Deviation 17.8

PRIMARY outcome

Timeframe: From discharge through the 6 month follow-up

The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Major Adverse Events	0 events

SECONDARY outcome

Timeframe: measured at time of procedure

Population: Per protocol. All enrolled patients

Acute procedural success, defined as achievement of </= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of </=30%.

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Procedural Success	98.5 percent with </=30% RS

SECONDARY outcome

Timeframe: measured at time of procedure

Population: Analysis per protocol

Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).

Outcome measures

Measure	Laser Treatment n=48 Participants CLiRpath Photoablation Atherectomy System
Minimum and Maximum Lumen Diameters Post pilot channel max lumen diameter	4.2 millimeters Standard Deviation 1.1
Minimum and Maximum Lumen Diameters Post Turbo-Booster max lumen diameter	5.1 millimeters Standard Deviation 0.8
Minimum and Maximum Lumen Diameters Post pilot channel min lumen diameter	1.9 millimeters Standard Deviation 0.6
Minimum and Maximum Lumen Diameters Post Turbo-Booster min lumen diameter	2.2 millimeters Standard Deviation 0.8

SECONDARY outcome

Timeframe: measured post discharge thorugh 12 Months follow-up

Population: 65 patients at 30 days; 59 at 6 months; 46 at 12 months

Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Clinical Success 30 days; n=65	96.9 percent of patients
Clinical Success 6 months; n=59	59.3 percent of patients
Clinical Success 12 months; n=46	54.3 percent of patients

SECONDARY outcome

Timeframe: Through 12 Months

Population: 65 at 30 days; 64 at 6 months; 63 at 12 months

Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Assisted Primary Patency 30 days; n=65	100 % pts free from assisted primary patency
Assisted Primary Patency 6 months; n=64	85.9 % pts free from assisted primary patency
Assisted Primary Patency 12 months; n=63	76.2 % pts free from assisted primary patency

SECONDARY outcome

Timeframe: Through 12 Month

Population: 65 at 30 days; 64 at 6 months; 63 at 12 months

Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Assisted Secondary Patency 30 days; n=65	100 % pts free from secondary patency
Assisted Secondary Patency 6 months; n=64	100 % pts free from secondary patency
Assisted Secondary Patency 12 months; n=63	100 % pts free from secondary patency

SECONDARY outcome

Timeframe: Through 12 Month

Population: per protocol; 65 patients at 30 days; 59 at 6 months and 46 at 12 months

Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Patients With >50% Stenosis Measured by Duplex Ultrasound 30 days; n=65	3.1 percent of patients
Patients With >50% Stenosis Measured by Duplex Ultrasound 6 months; n=59	40.7 percent of patients
Patients With >50% Stenosis Measured by Duplex Ultrasound 12 months; n=46	45.7 percent of patients

SECONDARY outcome

Timeframe: Through 12 Months

Population: 63 at baseline; 62 at 30days and 6 months; 63 at 12 months

Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Rutherford Classification baseline; n=63	2.4 units on a scale of 0-6 Standard Deviation 0.6
Rutherford Classification 30 days; n=62	1.0 units on a scale of 0-6 Standard Deviation 0.8
Rutherford Classification 6 months; n=62	1.3 units on a scale of 0-6 Standard Deviation 1.1
Rutherford Classification 12 months; n=63	1.3 units on a scale of 0-6 Standard Deviation 0.9

SECONDARY outcome

Timeframe: Through 12 Months

Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Adverse Events Procedure/24 hours	10 events
Adverse Events 30 days	7 events
Adverse Events 6 months	15 events
Adverse Events 12 months	15 events
Adverse Events Other	31 events

SECONDARY outcome

Timeframe: measured at time of procedure

Population: Per protocol

Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.

Outcome measures

Measure	Laser Treatment n=48 Participants CLiRpath Photoablation Atherectomy System
Volumetric Plaque Reduction Post pilot channel plaque volume	200.8 millimeters cubed Standard Deviation 61.0
Volumetric Plaque Reduction Post Turbo Booster plaque volume	192.8 millimeters cubed Standard Deviation 61.2

POST_HOC outcome

Timeframe: measured at each follow-up period

Population: 65 patients at baseline and 30 days; 64 at 6 mo; 63 at 12 mo

Measures difficulty in walking before and after treatment. Defined by comparing the responses to a WIQ at pre-treatment with the responses at 30 days, six (6) months and 12 months post-procedure. Higher score is better (scale 0-100).

Outcome measures

Measure	Laser Treatment n=65 Participants CLiRpath Photoablation Atherectomy System
Walking Impairment Questionare (WIQ) baseline; n=65	45.6 units on a scale 0-100 Standard Deviation 21.3
Walking Impairment Questionare (WIQ) 30 days; n=65	69.9 units on a scale 0-100 Standard Deviation 23.7
Walking Impairment Questionare (WIQ) 6 months; n=64	64.7 units on a scale 0-100 Standard Deviation 27.1
Walking Impairment Questionare (WIQ) 12 months; n=63	65.1 units on a scale 0-100 Standard Deviation 25.3

Adverse Events

Laser Treatment

Serious events: 11 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Laser Treatment n=65 participants at risk CLiRpath Photoablation Atherectomy System
Cardiac disorders Worsening coronary artery disease	1.5% 1/65
Vascular disorders Right renal artery and non-treated leg stenosis	1.5% 1/65
Cardiac disorders Coronary artery bypass graft	3.1% 2/65
Cardiac disorders Congestive heart failure	3.1% 2/65
Vascular disorders Vessel occlusion	1.5% 1/65
Respiratory, thoracic and mediastinal disorders Lung cancer	1.5% 1/65
General disorders Neck, back and shoulder pain	1.5% 1/65
Infections and infestations Sternum infection	1.5% 1/65
Vascular disorders Cerebrovascular accident	1.5% 1/65

Other adverse events

Measure	Laser Treatment n=65 participants at risk CLiRpath Photoablation Atherectomy System
Surgical and medical procedures Hematoma at access site	6.2% 4/65
Vascular disorders Occlusion to treated leg other than at lesion site	6.2% 4/65

Additional Information

Thomas M. Rasmussen V.P. Clinical Affairs

Spectranetics Inc

Phone: 719-447-2471

Email: thomas.rasmussen@spnc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place