Trial Outcomes & Findings for Resolute Integrity US Extended Length Sub-Study(RI US XL) (NCT NCT01913600)
NCT ID: NCT01913600
Last Updated: 2019-05-08
Results Overview
The combined clinical outcome of (all cause) mortality, MI or any revascularization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
12 months
Results posted on
2019-05-08
Participant Flow
56 XL subjects were enrolled from 9 study sites in the United States. The first subject was enrolled on July 26, 2013 and the last subject was enrolled on October 27, 2015.
Participant milestones
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Baseline characteristics by cohort
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
The combined clinical outcome of (all cause) mortality, MI or any revascularization
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=54 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Composite Endpoint: Major Adverse Cardiac Events (MACE)
30 Days
|
2 Participants
|
|
Composite Endpoint: Major Adverse Cardiac Events (MACE)
180 Days
|
2 Participants
|
|
Composite Endpoint: Major Adverse Cardiac Events (MACE)
360 Days
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Composite Endpoint: Target Lesion Failure (TLF)
30 Days
|
2 Participants
|
|
Composite Endpoint: Target Lesion Failure (TLF)
180 Days
|
2 Participants
|
|
Composite Endpoint: Target Lesion Failure (TLF)
360 Days
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Composite Endpoint: Target Vessel Failure (TVF),
30 Days
|
2 Participants
|
|
Composite Endpoint: Target Vessel Failure (TVF),
180 Days
|
2 Participants
|
|
Composite Endpoint: Target Vessel Failure (TVF),
360 Days
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Combined rate of cardiac death and target vessel MI post-procedure
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Composite Endpoint: Cardiac Death and Target Vessel MI
30 Days
|
2 Participants
|
|
Composite Endpoint: Cardiac Death and Target Vessel MI
180 Days
|
2 Participants
|
|
Composite Endpoint: Cardiac Death and Target Vessel MI
360 Days
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Composite Endpoint: Target Vessel MI
30 Days
|
2 Participants
|
|
Composite Endpoint: Target Vessel MI
180 Days
|
2 Participants
|
|
Composite Endpoint: Target Vessel MI
360 Days
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
All deaths including cardiac death, vasular death and non-cardiovascular death
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Clinical Endpoint: Death
30 Days
|
0 Participants
|
|
Clinical Endpoint: Death
180 Days
|
0 Participants
|
|
Clinical Endpoint: Death
360 Days
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Clinical Endpoint: Myocardial Infarction (MI)
30 Days
|
2 Participants
|
|
Clinical Endpoint: Myocardial Infarction (MI)
180 Days
|
2 Participants
|
|
Clinical Endpoint: Myocardial Infarction (MI)
360 Days
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Clinical Endpoint: Target Lesion Revascularization (TLR)
30 Days
|
0 Participants
|
|
Clinical Endpoint: Target Lesion Revascularization (TLR)
180 Days
|
0 Participants
|
|
Clinical Endpoint: Target Lesion Revascularization (TLR)
360 Days
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Repeat PCI or CABG of the target vessel.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Clinical Endpoint: Target Vessel Revascularization (TVR)
360 Days
|
1 Participants
|
|
Clinical Endpoint: Target Vessel Revascularization (TVR)
30 Days
|
0 Participants
|
|
Clinical Endpoint: Target Vessel Revascularization (TVR)
180 Days
|
0 Participants
|
SECONDARY outcome
Timeframe: Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)Population: 2 subjects did not complete the 12 month follow up
All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Clinical Endpoint: Stent Thrombosis
Early Thrombosis (<=30 days)
|
1 Participants
|
|
Clinical Endpoint: Stent Thrombosis
Late Thrombosis (31-360 days)
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Clinical Endpoint: Stroke
30 Days
|
0 Participants
|
|
Clinical Endpoint: Stroke
180 Days
|
0 Participants
|
|
Clinical Endpoint: Stroke
360 Days
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: 2 subjects did not complete the 12 month follow up
Bleeding complications in general including the GUSTO classification of Severe, Moderate \& Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Clinical Endpoint: Bleeding Complications in General
30 Days
|
3 Participants
|
|
Clinical Endpoint: Bleeding Complications in General
180 Days
|
6 Participants
|
|
Clinical Endpoint: Bleeding Complications in General
360 Days
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: At the time of the 12 month follow up there were 52 subjects with evaluable data
Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.
Outcome measures
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 Participants
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Dual Antiplatelet Therapy (DAPT) Compliance
30 Days
|
47 Participants
|
|
Dual Antiplatelet Therapy (DAPT) Compliance
180 Days
|
47 Participants
|
|
Dual Antiplatelet Therapy (DAPT) Compliance
360 Days
|
40 Participants
|
Adverse Events
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
Serious events: 45 serious events
Other events: 45 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 participants at risk
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Cardiac disorders
Acute MI
|
5.4%
3/56 • 1 Year
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/56 • 1 Year
|
|
Cardiac disorders
Angina Unstable
|
7.1%
4/56 • 1 Year
|
|
Cardiac disorders
Atrial Fibrilation
|
1.8%
1/56 • 1 Year
|
|
Cardiac disorders
Atrial Flutter
|
1.8%
1/56 • 1 Year
|
|
Cardiac disorders
Cardiac Failure
|
1.8%
1/56 • 1 Year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.6%
2/56 • 1 Year
|
|
Cardiac disorders
Coronary Artery Disease
|
3.6%
2/56 • 1 Year
|
|
Cardiac disorders
Coronary Artery Dissection
|
5.4%
3/56 • 1 Year
|
|
Eye disorders
Retinal Detachment
|
1.8%
1/56 • 1 Year
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
1/56 • 1 Year
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.8%
1/56 • 1 Year
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
1.8%
1/56 • 1 Year
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
1.8%
1/56 • 1 Year
|
|
Gastrointestinal disorders
Polyp Colerectal
|
1.8%
1/56 • 1 Year
|
|
General disorders
Chest pain
|
1.8%
1/56 • 1 Year
|
|
Hepatobiliary disorders
Ischaemic Hepatitis
|
1.8%
1/56 • 1 Year
|
|
Infections and infestations
Bronchitis
|
1.8%
1/56 • 1 Year
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/56 • 1 Year
|
|
Infections and infestations
Pneumonia
|
1.8%
1/56 • 1 Year
|
|
Infections and infestations
Postoperative Wound Infection
|
1.8%
1/56 • 1 Year
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.8%
1/56 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.8%
1/56 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
1.8%
1/56 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
1.8%
1/56 • 1 Year
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.8%
1/56 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.8%
1/56 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
1.8%
1/56 • 1 Year
|
|
Vascular disorders
Hypertension
|
3.6%
2/56 • 1 Year
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • 1 Year
|
|
Vascular disorders
Intermittent Claudication
|
1.8%
1/56 • 1 Year
|
|
Vascular disorders
Orthostatic Hypotension
|
1.8%
1/56 • 1 Year
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
1.8%
1/56 • 1 Year
|
|
Vascular disorders
Vasospasm
|
1.8%
1/56 • 1 Year
|
Other adverse events
| Measure |
Resolute Integrity US Extended Length Sub-Study (RI-US XL)
n=56 participants at risk
Resolute Integrity Stent
Resolute Integrity Stent: Drug eluting stent (DES)
Description - Patients with at least one lesion amendable to treatment with a 34 or 38 mm length stent. For those subjects with a second lesion, the second lesion may be treated with any available size study stent. Subjects treated with a 34mm or 38mm length stent were designated as a participant in the XL sub study regardless of the length of any other stent that was implanted as part of the study procedure.
|
|---|---|
|
Cardiac disorders
Palpitations
|
8.9%
5/56 • 1 Year
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
4/56 • 1 Year
|
|
General disorders
Chest Pain
|
19.6%
11/56 • 1 Year
|
|
General disorders
Fatigue
|
7.1%
4/56 • 1 Year
|
|
Infections and infestations
Bronchitis
|
8.9%
5/56 • 1 Year
|
|
Investigations
Cardiac Enzymes Increased
|
14.3%
8/56 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
5.4%
3/56 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.9%
5/56 • 1 Year
|
Additional Information
Lisa Bousquette, Clinical Research Director
Medtronic, Coronary & Structural Heart Clinical
Phone: 707-591-2967
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place