Paximusâ?¢ Randomized Controlled Trial
- Conditions
- Health Condition 1: I739- Peripheral vascular disease, unspecified
- Registration Number
- CTRI/2019/05/018886
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or non-pregnant female >=18 to <=80 years of age.
2. Patient or his/her legally acceptable representative (LAR) willing to provide informed consent and comply with the required study procedures and visits.
3. Patient agrees not to participate in any other investigational or invasive clinical study for a period of 2 years from the date of index procedure.
4. Female patient of childbearing potential who does not plan pregnancy for up to 2 years from the date of index procedure. For a female patient of childbearing potential a pregnancy test must be performed with negative results at screening visit.
5. Female patient not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 2 years from the date of index procedure.
6. Clinically all patients must be in Rutherford category 2 to 5.
7. One identifiable single solitary or a series of multiple adjacent lesions in the blocked or narrowed arteries below the knee due toPeripheral Artery Disease (PAD) defined as >=70% diameter stenosis with length in the range of >=20 mm to <=150 mm.
8. If the index lesion is re-stenotic, the prior PTA must have been >30 days prior to treatment in the current study
9. Patients planned for PK analysis must agree to undergo PK follow-ups as per protocol.
1. Patient with known hypersensitivity to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
2. Patient with known allergies or sensitivity to paclitaxel.
3. Patient having gastrointestinal bleeding or coagulopathy.
4. Patient having target lesion that the investigator is unable to cross by a guide wire.
5. Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper of the delivery system.
6. Patient is probable case of stenting for the target lesion during the screening as per adjudication of investigator.
7. Patient with severe renal insufficiency (serum creatinine >2.0 mg/dL).
8. Untreated ipsilateral iliac artery.
9. Acute aneurysm in target the target vessel.
10. Patient participating in another device or drug study at the time of consenting process.
11. Major surgical procedures (viz. major invasive procedures or endovascular interventions for peripheral artery disease etc. or surgeries that might impact safety of participating patients as per discretion of investigator) within 30 days prior to this study or planned within 2 years after entry into this study.
12. Patient with life expectancy less than 2 years.
13. Adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon etc) within 30 days prior to this study or planned within 30 days of entry into this study.
14. Patient who required bailout stenting.
15. Diagnosed with cancer or malignancy
16. Any medical condition, which in investigatorâ??s opinion, may interfere with patientâ??s participation in the study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major adverse event [Time Frame: 6 months] <br/ ><br>- Major adverse event is defined as all-cause death, target limb amputation and clinically driven target lesion revascularization (CD-TLR)Timepoint: 6 Months
- Secondary Outcome Measures
Name Time Method All cause of deathTimepoint: At Post-procedure, 1 month, 6 months , 12 months and 24 months;Change in Rutherford ClassificationTimepoint: At Baseline, Post-procedure, 1 month, 6 months, 12 months and 24 months;Change of Ankle-Brachial index (ABI)Timepoint: At Baseline, Post-procedure, 1 month, 6 months , 12 months and 24 months;Clinically driven TLR (CD-TLR)Timepoint: At Post-procedure, 1 month, 6 months , 12 months and 24 months;Device SuccessTimepoint: During index procedure;Late Lumen LossTimepoint: At post-procedure and after 6 months;Primary PatencyTimepoint: At post-procedure and after 6 months;Procedural SuccessTimepoint: At Post-procedure;Target limb amputationTimepoint: At Post-procedure, 1 month, 6 months , 12 months and 24 months;User Rating on Technical PropertiesTimepoint: At index procedure;Walking Impairment Questionnaire (WIQ)Timepoint: At 1 month, 6 months, 12 months and 24 months